Alpha System

by Zimmer, Inc.

510(k) K950312

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

510(k) K950312↗

FDA record

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SN Traditional	NumberK950312	Date17 May 1995Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K950312

Recalls

3 recalls · FDA

2 recalls, same reason
- Terminated Z-1164-2016 FDA Class II initiated 11 Jan 2016
- Terminated Z-1167-2016 FDA Class II initiated 11 Jan 2016
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Terminated Z-1029-2014 FDA Class II initiated 11 Oct 2013
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

Timeline

4 dated events

17 May 1995 Cleared FDA 510(k) K950312
11 Oct 2013 Recall initiated FDA recalls Z-1029-2014
11 Jan 2016 Recall initiated FDA recalls Z-1164-2016
11 Jan 2016 Recall initiated FDA recalls Z-1167-2016

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K950312
FDA product code: JDI

Device class: Class II
Regulation: 21 CFR Part 888.3350
Advisory committee: Orthopedic
FDA decision: SN

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Alpha System is an orthopedic device. It received FDA 510(k) clearance as substantially equivalent for some indications.

The device was cleared through the traditional 510(k) process by Zimmer, Inc. It is identified by K number K950312 and product code JDI. The authorization decision was made on May 17, 1995.

Devices cleared under K950312

38 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K950312
		UDI-DI	Size and differences
1109-11 Zimmer, Inc.	1109-11	00889024432918	—	On the market
VerSys® 7859-09 Zimmer, Inc.	00-7859-009-00 / 7859-09	00889024138667	Outer Diameter 9 mm	On the market
VerSys® Advocate® 7850-11 Zimmer, Inc.	00-7850-011-00 / 7850-11	00889024138063	—	On the market
VerSys® Advocate® 7850-11-50 Zimmer, Inc.	00-7850-011-50 / 7850-11-50	00889024138087	—	On the market
VerSys® Advocate® 7850-12 Zimmer, Inc.	00-7850-012-00 / 7850-12	00889024138094	—	On the market
VerSys® Advocate® 7850-12-20 Zimmer, Inc.	00-7850-012-20 / 7850-12-20	00889024138117	—	On the market
VerSys® Advocate® 7850-12-50 Zimmer, Inc.	00-7850-012-50 / 7850-12-50	00889024138131	—	On the market
VerSys® Advocate® 7850-13 Zimmer, Inc.	00-7850-013-00 / 7850-13	00889024138148	—	On the market
VerSys® Advocate® 7850-13-20 Zimmer, Inc.	00-7850-013-20 / 7850-13-20	00889024138162	—	On the market
VerSys® Advocate® 7850-13-50 Zimmer, Inc.	00-7850-013-50 / 7850-13-50	00889024138186	—	On the market
VerSys® Advocate® 7850-14 Zimmer, Inc.	00-7850-014-00 / 7850-14	00889024138193	—	On the market
VerSys® Advocate® 7850-14-20 Zimmer, Inc.	00-7850-014-20 / 7850-14-20	00889024138216	—	On the market
VerSys® Advocate® 7850-14-50 Zimmer, Inc.	00-7850-014-50 / 7850-14-50	00889024138230	—	On the market
VerSys® Advocate® 7850-15 Zimmer, Inc.	00-7850-015-00 / 7850-15	00889024138247	—	On the market
VerSys® Advocate® 7850-15-20 Zimmer, Inc.	00-7850-015-20 / 7850-15-20	00889024138261	—	On the market
VerSys® Advocate® 7850-15-50 Zimmer, Inc.	00-7850-015-50 / 7850-15-50	00889024138285	—	On the market
VerSys® Advocate® 7850-16 Zimmer, Inc.	00-7850-016-00 / 7850-16	00889024138292	—	On the market
VerSys® Advocate® 7850-16-20 Zimmer, Inc.	00-7850-016-20 / 7850-16-20	00889024138315	—	On the market
VerSys® Advocate® 7850-16-50 Zimmer, Inc.	00-7850-016-50 / 7850-16-50	00889024138339	—	On the market
VerSys® Advocate® 7850-17 Zimmer, Inc.	00-7850-017-00 / 7850-17	00889024138346	—	On the market
VerSys® Advocate® 7850-17-50 Zimmer, Inc.	00-7850-017-50 / 7850-17-50	00889024138360	—	On the market
VerSys® Advocate® 7850-22-50 Zimmer, Inc.	00-7850-022-50 / 7850-22-50	00889024138377	—	On the market
VerSys® Advocate® 7850-23-50 Zimmer, Inc.	00-7850-023-50 / 7850-23-50	00889024138384	—	On the market
VerSys® Advocate® 7850-24-50 Zimmer, Inc.	00-7850-024-50 / 7850-24-50	00889024138391	—	On the market
VerSys® Advocate® 7850-25-50 Zimmer, Inc.	00-7850-025-50 / 7850-25-50	00889024138407	—	On the market
VerSys® Advocate® 7850-26-50 Zimmer, Inc.	00-7850-026-50 / 7850-26-50	00889024138414	—	On the market
VerSys® Advocate® V-Lign® 7850-11-05 Zimmer, Inc.	00-7850-011-05 / 7850-11-05	00889024138070	—	On the market
VerSys® Advocate® V-Lign® 7850-12-05 Zimmer, Inc.	00-7850-012-05 / 7850-12-05	00889024138100	—	On the market
VerSys® Advocate® V-Lign® 7850-12-25 Zimmer, Inc.	00-7850-012-25 / 7850-12-25	00889024138124	—	On the market
VerSys® Advocate® V-Lign® 7850-13-05 Zimmer, Inc.	00-7850-013-05 / 7850-13-05	00889024138155	—	On the market
VerSys® Advocate® V-Lign® 7850-13-25 Zimmer, Inc.	00-7850-013-25 / 7850-13-25	00889024138179	—	On the market
VerSys® Advocate® V-Lign® 7850-14-05 Zimmer, Inc.	00-7850-014-05 / 7850-14-05	00889024138209	—	On the market
VerSys® Advocate® V-Lign® 7850-14-25 Zimmer, Inc.	00-7850-014-25 / 7850-14-25	00889024138223	—	On the market
VerSys® Advocate® V-Lign® 7850-15-05 Zimmer, Inc.	00-7850-015-05 / 7850-15-05	00889024138254	—	On the market
VerSys® Advocate® V-Lign® 7850-15-25 Zimmer, Inc.	00-7850-015-25 / 7850-15-25	00889024138278	—	On the market
VerSys® Advocate® V-Lign® 7850-16-05 Zimmer, Inc.	00-7850-016-05 / 7850-16-05	00889024138308	—	On the market
VerSys® Advocate® V-Lign® 7850-16-25 Zimmer, Inc.	00-7850-016-25 / 7850-16-25	00889024138322	—	On the market
VerSys® Advocate® V-Lign® 7850-17-05 Zimmer, Inc.	00-7850-017-05 / 7850-17-05	00889024138353	—	On the market

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