Responsive Orthopedics Total Knee Arthroplasty System

FDA UDI

Class II (US FDA UDI)

by Responsive Orthopedics Llc

Identity

Trade Name: Responsive Orthopedics Total Knee Arthroplasty System FDA UDI
Generic Name: Polyethylene patella prosthesis FDA UDI
Device Name: Patella Oval, 38mm FDA UDI
Model / Reference: 90-SRK-410300 FDA UDI
Description: Patella Oval, 38mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00841973102120 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Polyethylene patella prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Polyethylene patella prosthesis

Responsive Orthopedics Total Knee Arthroplasty System by Responsive Orthopedics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyethylene patella prosthesis.

VANGUARD KNEE SYSTEM — Biomet Orthopedics, Inc. · Class II
Duracon — Howmedica Osteonics Corp. · Class II
PERSONA® — Zimmer, Inc. · Class II
S-ROM NOILES — DEPUY (IRELAND) · Class II
LOSPA Total Knee System — Corentec Co., Ltd · Class II
ADVANCE® — MicroPort Orthopedics Inc. · Class II
Unity Total Knee System — CORIN LTD · Class II
Proven Gen-Flex PS Knee System — GLOBUS MEDICAL, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Responsive Orthopedics Llc

Sources (1)

FDA UDI 53d5398e-9b84-4685-870d-4198af621b11 33 fields · synced May 31, 2026