ALPHA SYSTEM— 510(k) K950312

Clearance details

Applicant

Zimmer, Inc.

Product code

Code JDI

Device class

Class 2

Regulation

21 CFR 888.3350

Advisory panel

Orthopedic

Date received

1995-01-26

Decision date

1995-05-17

Decision

Substantially Equivalent for Some Indications

Clearance type

Traditional

Location

Warsaw, IN, US

• K253515 — Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments2026-08-24
• K253434 — OSSTM Orthopedic Salvage System2026-07-01
• K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners2025-07-31
• K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems2024-10-21
• K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component2024-08-02

• K260831 — Z1 Hip System2026-06-16
• K261683 — Augment Off-Axis Instrument System2026-06-16
• K251840 — Zimmer® Persona® Personalized Knee System2026-05-28
• K260182 — Avenir® Müller Stem; Avenir Complete Hip System2026-04-27
• K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)2026-04-13

Death

65

Injury

12,943

Malfunction

1,681

Total

14,689

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1164-2016 — Product 66 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE CEMENTED 785001300 VERSYS ADVOCATE CEMENTED 785001320 VERSYS ADVOCATE CEMENTED 785001400 VERSYS ADVOCATE CEMENTED 785001420 VERSYS ADVOCATE CEMENTED 785001500 VERSYS ADVOCATE CEMENTED 785001520 VERSYS ADVOCATE CEMENTED 785001600 VERSYS ADVOCATE CEMENTED 785001620 VERSYS ADVOCATE CEMENTED 785001700 VERSYS ADVOCATE CEMENTED 785001305 VERSYS ADVOCATE V-LIGN CE 785001325 VERSYS ADVOCATE V-LIGN CE 785001405 VERSYS ADVOCATE V-LIGN CE 785001505 VERSYS ADVOCATE V-LIGN CE 785001525 VERSYS ADVOCATE V-LIGN CE For use in total or hemi hip arthroplastyClass II·Terminated·Zimmer Manufacturing B.V.·20160111
• Z-1167-2016 — Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 VERSYS CEMENTED FEM STEM 785301521 VERSYS CEMENTED FEM STEM 15X140MM X-OFF 785301601 VERSYS CEMENTED FEM STEM 16X145MM For use in total or hemi hip arthroplastyClass II·Terminated·Zimmer Manufacturing B.V.·20160111
• Z-1029-2014 — 12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM LD/FX SZ 14X13 VERSYS CEM LD/FX SZ 16X14 VERSYS CEM LD/FX ST 18X15 VERSYS PRESS FIT LD/FX ST VERSYS PRESS FIT LD/FX SZ VERSYS ADVOCATE CEMENTED VERSYS ADVOCATE V-LIGN CE VERSYS CEMENTED FEM STEM VERSYS CT FEM STEM 11X120 VERSYS CT FEM STEM 12X125 VERSYS CT FEM STEM 13X130 VERSYS CT FEM STEM 14X135 VERSYS CT FEM STEM 15X140 VERSYS CT FEM STEM 16X145 VERSYS CT FEM STEM 17X150 VERSYS CEM/REV/CALCAR 13X VERSYS CEM/REV/CALCAR 15X VERSYS CEM/REV/CALCAR 17X VERSYS CEM/REV/CALCAR 19XClass II·Terminated·Zimmer, Inc.·20131011

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K950312.