Chrysalis Intelligence · Sponsors · Tyber Medical, LLC

Tyber Medical, LLC

Bethlehem, PA, US · 20 510(k) clearances · 20 recalls

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Total clearances
20
2020-01-08 → 2026-06-12
Last 12 months
6
Product codes
6
Most recent
2026-06-12
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HRS Plate, Fixation, Bone Class II Orthopedic 11 2026-06-12
HWC Screw, Fixation, Bone Class II Orthopedic 4 2026-04-03
OLO Orthopedic Stereotaxic Instrument Class II Neurology 2 2026-05-29
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Class II Orthopedic 1 2026-06-10
HTY — — — 1 2023-07-06
JDR Staple, Fixation, Bone Class II Orthopedic 1 2022-10-20
Safety

Recalls (20)

Class I (serious)
0
Risk of injury / death
Total recalls
20
Currently ongoing
20
Most recent
2025-12-19
DateSeverityStatusRecall # ProductCodeReason
2025-12-19 Class II Ongoing Z-1132-2026 Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Mo… — The supplier manufactured anatomical left plates with an incorrect thread orientation.
2025-12-19 Class II Ongoing Z-1131-2026 Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Mo… — The supplier manufactured anatomical left plates with an incorrect thread orientation.
2025-01-21 Class II Ongoing Z-1226-2025 A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right Intended Fixation of fractures of the dista… — Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibul…
2025-01-21 Class II Ongoing Z-1225-2025 A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate, 16-Hole, Left Intended for Fixation of fractures of the dis… — Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibul…
2025-01-21 Class II Ongoing Z-1224-2025 A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures of the di… — Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibul…
2025-01-21 Class II Ongoing Z-1223-2025 A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of the dista… — Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibul…
2025-01-21 Class II Ongoing Z-1222-2025 A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended Fixation of fractures of the distal … — Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibul…
2025-01-21 Class II Ongoing Z-1221-2025 A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. Intended Fixation of fractures of the dista… — Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibul…
2025-01-21 Class II Ongoing Z-1220-2025 A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Model/Catalog Number: 770715062 Intended for … — Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibul…
2025-01-21 Class II Ongoing Z-1219-2025 A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for Fixation of fractures of the distal… — Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibul…
2025-01-21 Class II Ongoing Z-1218-2025 A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right. Intended for Fixation of fr… — Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibul…
2025-01-21 Class II Ongoing Z-1217-2025 A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate, 12-Hole, Left. Inended for Fixation of fr… — Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibul…
2025-01-21 Class II Ongoing Z-1216-2025 A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole, Right. Intended forFixation of fra… — Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibul…
2025-01-21 Class II Ongoing Z-1215-2025 A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fibula Plate, 10-Hole, Left. Intended Fixati… — Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibul…
2025-01-21 Class II Ongoing Z-1214-2025 A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right Indicated for use in Fixation … — Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibul…
2025-01-21 Class II Ongoing Z-1213-2025 A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended to bridge or otherwise… — Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibul…
2025-01-21 Class II Ongoing Z-1212-2025 A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole, Right Model/Catalog Number: 77070806… — Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibul…
2025-01-21 Class II Ongoing Z-1211-2025 A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole, Left Intended for Fixation of fractu… — Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibul…
2025-01-21 Class II Ongoing Z-1210-2025 A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole, Right Model/Catalog Number: 77070804… — Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibul…
2025-01-21 Class II Ongoing Z-1209-2025 A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left Intended for Fixation of fract… — Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibul…
Filings

All 510(k) clearances (20)

Date K-number Device Code Class Specialty
2026-06-12 K261207 Exalta Proximal Tibia Plating System HRS Class II Orthopedic
2026-06-10 K260810 Anteralign LS coverplate OVD Class II Orthopedic
2026-05-29 K261060 Navigated LLIF Impactable Tracker OLO Class II Neurology
2026-04-03 K253042 Tyber Medical Trauma Screw HWC Class II Orthopedic
2025-12-31 K252901 Tyber Medical Trauma Screw HWC Class II Orthopedic
2025-10-28 K252742 Navigated Instruments OLO Class II Neurology
2025-07-30 K251361 Tyber Medical Distal Radius Plating System HRS Class II Orthopedic
2025-03-19 K242486 Tyber Medical Anatomical Plating System HRS Class II Orthopedic
2024-05-31 K241218 Tyber Medical Anatomical Plating System HRS Class II Orthopedic
2023-12-21 K233423 Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System HRS Class II Orthopedic
2023-12-20 K233017 TM Plating System HRS Class II Orthopedic
2023-12-13 K232652 Anatomical Plating System (various) HRS Class II Orthopedic
2023-12-04 K232693 Tyber Medical Distal Radius Plating System HRS Class II Orthopedic
2023-07-06 K231339 Tyber Medical Pin and Wire System (various) HTY — —
2023-03-07 K222465 Tyber Medical Anatomical Plating System HRS Class II Orthopedic
2022-10-20 K221947 Tyber Medical Staple Fixation System (various) JDR Class II Orthopedic
2021-08-13 K203817 Tyber Medical Anatomical Plating System HRS Class II Orthopedic
2020-01-20 K193222 Tyber Medical Anatomical Plating System HRS Class II Orthopedic
2020-01-09 K192975 Tyber Medical Trauma Screws HWC Class II Orthopedic
2020-01-08 K192974 Tyber Medical Trauma Screw HWC Class II Orthopedic
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence