Chrysalis Intelligence · Sponsors · Riverpoint Medical

Riverpoint Medical

Portland, OR, US · 27 510(k) clearances · 42 recalls

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Total clearances
27
2020-09-10 → 2026-08-27
Last 12 months
4
Product codes
4
Most recent
2026-08-27
Name variants in FDA filings: Riverpoint Medical, LLC / Riverpoint Medical
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MBI Fastener, Fixation, Nondegradable, Soft Tissue Class II Orthopedic 21 2026-08-27
GAT Suture, Nonabsorbable, Synthetic, Polyethylene Class II General, Plastic Surgery 4 2025-10-16
HRS Plate, Fixation, Bone Class II Orthopedic 1 2024-08-19
JDQ Cerclage, Fixation Class II Orthopedic 1 2023-07-26
Safety

Recalls (42)

Class I (serious)
0
Risk of injury / death
Total recalls
42
Currently ongoing
1
Most recent
2023-10-25
DateSeverityStatusRecall # ProductCodeReason
2023-10-25 Class II Ongoing Z-0518-2024 Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S … — Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may als…
2020-12-09 Class II Terminated Z-0949-2021 Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 1… — Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and pos…
2020-08-03 Class II Terminated Z-0049-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-13 Cutting SV2298, UDI: 20884521151021 - … — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0048-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting SV935, UDI: 20884521151755 - P… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0047-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper CV3110, UDI: 20884521150918 - P… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0046-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting SV426, UDI: 20884521151731 - P… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0045-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" GS-20 CV9975G, UDI: 20884521149585 - Produc… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0044-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-12 Cutting SV497G, UDI: 20884521149707 - … — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0043-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" KV-15 TaperCutting CV2279, UDI: 20884521151… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0042-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25 CV605, UDI: 20884521152295 - Product … — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0041-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" PC-11 SV487G, UDI: 10884521149595 - Produ… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0040-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting SV426, UDI: 20884521151731 -… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0039-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-25 CV604, UDI: 20884521152288 - Product … — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0038-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-11 SVP2295, UDI: 20884521177410 - Product… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0037-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-11 Cutting CV4731, UDI: 20884521151359 - P… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0036-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-21 Taper CV946, UDI: 20884521151298 - Prod… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0035-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" C-12 Cutting, Product Number: SV2295, UDI: … — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0034-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25, Product Number: CV605, UDI: 2088452115… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0033-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 36" KV-34, TaperCutting Product Number: CV916, … — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0032-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" PC-10, Product Number: SV835G, UDI: 2088452… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0031-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" KV-11, TaperCutting, Product Number: CV2293… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0030-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-14, Product Number: SVP2251, UDI: 2088452… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0029-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cut, Product Number: SV496, UDI: 20884… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0028-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" CV-23 Taper, Product Number: CV1213, UDI: 2… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0027-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-21 Taper, Product Number: CV947, UDI: 2088… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0026-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" V-20 Taper, Product Number: CV416G, UDI: 20… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0025-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-12 Cutting, Product Number: SV496G, UDI: … — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0024-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" CV-25 Taper, Product Number: CV3100, UDI: 2… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0023-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 30" P-10 Cutting, Product Number: SV4893, UDI: … — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0022-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 VL 18" P-10, Product Number: SV32, UDI: 20884521153117… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0021-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" SC-1, Product Number: SV2239, UDI: 20884521… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0020-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-12, Cutting Product Number: CV486, UDI: 20… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0019-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-11, Product Number: SVP2294, UDI: 2088452… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0018-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper, Product Number: CV3110, UDI: 2… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0017-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 18" P-24, Product Number: SV9911G, UDI: 2088452… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0016-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 18" P-14 Cutting, Product Number: SV6830, UDI: 20… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0015-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" V-20 Taper, Product Number: CV417G, UDI: 208… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0014-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 208… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0013-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI:… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0012-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 208… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0011-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 208… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
2020-08-03 Class II Terminated Z-0010-2021 Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20… — The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.
Filings

All 510(k) clearances (27)

Date K-number Device Code Class Specialty
2026-08-27 K262677 Iconix Knotless T MBI Class II Orthopedic
2026-03-11 K253693 Strut Suture; No-Tie Button MBI Class II Orthopedic
2026-02-27 K253695 LigaMend MBI Class II Orthopedic
2025-10-16 K253024 ProZip Knotless Implant GAT Class II General, Plastic Surgery
2025-08-13 K252201 HS Fiber GAT Class II General, Plastic Surgery
2025-07-30 K252144 Iconix Speed Anchor; Iconix Speed HA+ Anchor MBI Class II Orthopedic
2025-03-20 K243988 RootMend MRR MBI Class II Orthopedic
2024-11-26 K242494 OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct MBI Class II Orthopedic
2024-11-19 K243323 Iconix Knotless Anchor MBI Class II Orthopedic
2024-10-29 K243203 OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor MBI Class II Orthopedic
2024-08-19 K241282 RibFix Titan™ Fixation System HRS Class II Orthopedic
2024-07-03 K241577 Iconix® Anchor MBI Class II Orthopedic
2024-04-11 K240719 OC JuggerKnot Soft Anchor MBI Class II Orthopedic
2024-02-23 K240213 Iconix Knotless Anchor MBI Class II Orthopedic
2024-02-21 K240194 ProCinch, QuadCinch MBI Class II Orthopedic
2024-01-05 K231163 HS Fiber Sutures GAT Class II General, Plastic Surgery
2023-11-30 K233552 IDEAL Ziploop MBI Class II Orthopedic
2023-11-14 K233468 Iconix Anchor MBI Class II Orthopedic
2023-10-06 K232411 JuggerKnot Soft Anchor OC MBI Class II Orthopedic
2023-10-05 K231078 All-Suture Anchor MBI Class II Orthopedic
2023-08-01 K231278 Knotless Suture Anchor MBI Class II Orthopedic
2023-07-26 K220765 HS Fiber Cerclage JDQ Class II Orthopedic
2023-05-17 K231128 JuggerKnot Soft Anchor MBI Class II Orthopedic
2023-02-23 K230212 OrthoButton AL MBI Class II Orthopedic
2021-02-12 K203740 JuggerKnot Soft Anchor MBI Class II Orthopedic
2020-09-18 K202399 OrthoButton FL MBI Class II Orthopedic
2020-09-10 K202242 HS Fiber GAT Class II General, Plastic Surgery
Data source: openFDA · Generated 2026-10-08 10:51 · Last ingest 2026-10-08T14:51:39.242493 · Pipeline: Chrysalis Intelligence