UKNEE Tibial insert, plained 2301-1213

by United Orthopedic Corp.

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 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Overview

The UKNEE Tibial insert, plained is a cruciate-retaining total knee prosthesis designed to replace damaged or degenerative knee joints. This implantable artificial substitute for the knee joint provides stability and support to the surrounding tissues.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04712602346320 UDI-DI	Date24 Oct 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberK021657	Date12 Aug 2002Issued	StatusActive

Official records

AccessGUDID record UDI-DI 04712602346320
FDA 510(k) database 510(k) number K021657

Across registries

2 registries list this device

FDA 510(k) K021657 decided 12 Aug 2002 Active
FDA GUDID UDI-DI 04712602346320 listed 24 Oct 2015 Listed

Timeline

2 dated events

12 Aug 2002 Cleared FDA 510(k) K021657
24 Oct 2015 Listed FDA GUDID 04712602346320

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: UKNEE Tibial insert, plained
Generic name: Cruciate-retaining total knee prosthesis
Model / Ref / Catalog: 2301-1213

Primary DI / UDI-DI: 04712602346320
510(k) Number: K021657
FDA product code: JWH
GMDN term: Cruciate-retaining total knee prosthesis

Device class: Class II
Regulation number: 888.3560
GUDID distribution status: In Commercial Distribution

Other devices from United Orthopedic Corp.

See all devices from United Orthopedic Corp. →

Properties

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

Other properties (9, all answered No)