Quantum M50 ST221

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number03701337601492 UDI-DI	Date26 Jun 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK191380	Date29 Jan 2020Decided	StatusActive

Official records

AccessGUDID record UDI-DI 03701337601492
FDA 510(k) database 510(k) number K191380

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Quantum
Generic name: Fixed-bearing total ankle prosthesis
Model / Ref / Catalog: M50 ST221

Primary DI / UDI-DI: 03701337601492
510(k) Number: K191380
FDA product code: HSN
GMDN term: Fixed-bearing total ankle prosthesis

Device class: Class II
Regulation number: 888.3110
GUDID distribution status: In Commercial Distribution

Size: Length — 34.58 Millimeter
Length — 28 Millimeter

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Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number
Expiration date

Other properties (9)

Sterilise before use: No
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