MiniMAX Stems 01.13.106R

by Medacta International

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07630030803260 UDI-DI	Date21 Aug 2017Listed	StatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

- Terminated Z-0196-2019 FDA Class II initiated 15 Nov 2017
Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: MiniMAX Stems
Generic Name: Press-fit hip femur prosthesis, one-piece
Model / Reference: 01.13.106R

Primary DI / UDI-DI: 07630030803260
510(k) Number: K170845
K250450
FDA Product Code: LZO, LZY, KWY, MEH
GMDN Term: Press-fit hip femur prosthesis, one-piece

Device Class: Class II
Regulation Number: 888.3353, 888.3360, 888.3390
GUDID distribution status: In Commercial Distribution

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Properties

Sterile
Single Use
Implantable
Prescription Use
Lot / Batch Number
Expiration Date

Other properties (8)

Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Manufacturing Date: No