Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays A-F) Ixford Partial Knee Replacement System

Q: What is the product code of K122277?

The FDA product code is HRY – Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3530.

FDA 510(k) K122277 · Biomet Manufacturing Corp

Substantially Equivalent

510(k) numberK122277

Submission

Device name: Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays A-F) Ixford Partial Knee Replacement System
Applicant: Biomet Manufacturing Corp
Warsaw, IN, US
Received: July 30, 2012
Decision date: October 22, 2012
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HRY – Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3530
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code HRY

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K193549	SIGMA High Performance (HP) Partial Knee SystemHRY · Traditional	Depuy Ireland UC	04/16/2020SE
K190633	NanoOrtho NanoKnee® SystemHRY · Traditional	Nanoortho, LLC	12/20/2019SE
K152631	MPO Total Knee Systems MR LabelingHRY · Traditional	Microport Orthopedics, Inc.	03/23/2016SE
K150410	Restoris Porous Partial Knee SystemHRY · Special	Mako Surgical Corporation	03/20/2015SE
K133940	Oxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)HRY · Traditional	Biomet UK, Ltd.	03/28/2014SE
K131167	UnivationHRY · Traditional	Aesculap Implant Systems, LLC	10/17/2013SE
K110415	Signature Planner / Signature GuidesHRY · Traditional	Materialise NV	05/16/2011SE
K100973	Evolution Unicondylar Knee SystemHRY · Traditional	Wrightmedicaltechnologyinc	08/10/2010SE
K082567	Stryker Compartmental Knee System Line ExtensionHRY · Special	Howmedica Osteonics Corp.	10/03/2008SE
K081293	Univation Unicondylar Knee SystemHRY · Traditional	Aesculap Implant Systems, Inc.	09/22/2008SE

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Questions and answers

When was Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays A-F) Ixford Partial Knee Replacement System cleared by the FDA?

Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays A-F) Ixford Partial Knee Replacement System (K122277) received a 510(k) decision of Substantially Equivalent on October 22, 2012, 84 days after the submission was received.

What is the product code of K122277?

The FDA product code is HRY – Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3530.