Quantum M50 SU115

Quantum M50 SU115 is a Class II device made by IN2BONES, cleared under FDA 510(k) K191380 on 29 Jan 2020 and listed in FDA GUDID since 26 Jun 2020 (UDI-DI 03701337601621), active as of 22 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number03701337601621 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 03701337601621
FDA 510(k) database 510(k) number K191380

Across registries

2 registries list this device

FDA 510(k) K191380 decided 29 Jan 2020 Active
FDA GUDID UDI-DI 03701337601621 listed 26 Jun 2020 Listed

Timeline

2 dated events

29 Jan 2020 Cleared FDA 510(k) K191380
26 Jun 2020 Listed FDA GUDID 03701337601621

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Withdrawn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 SU115

Primary DI / UDI-DI: 03701337601621
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 — 29.49 Millimeter
Length — 26 Millimeter

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Properties

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

Other properties (9, all answered No)