Chrysalis Intelligence · Sponsors · Riverpoint Medical

Riverpoint Medical

Portland, OR, US · 26 510(k) clearances · 42 recalls

Total clearances
26
2020-09-10 → 2026-03-11
Last 12 months
3
Product codes
4
Most recent
2026-03-11
Name variants in FDA filings: Riverpoint Medical / Riverpoint Medical, LLC
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 20 2026-03-11
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 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 (26)

Date K-number Device Code Class Specialty
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
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