Product Code: KWI FDA class 2 21 CFR 888.3170

Prosthesis, Elbow, Hemi-, Radial, Polymer

Orthopedic

The Polymer Radial Hemi Elbow Prosthesis is an orthopedic implant made from polymer material used to replace only the radial head side of the elbow joint, typically following radial head fracture or elbow joint disease, to restore forearm rotation and elbow stability. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is KWI, regulated under 21 CFR 888.3170, in the Orthopedic medical specialty. This device is an implant.

View on FDA

510(k)s

FEI Numbers

101

Registration Numbers

101

Unique Applicants

Years Active

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Basic Information

Product Code: KWI
Device Class: FDA class 2
Regulation Number: 888.3170
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 33 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K233592	BioPoly Radial Head Implant	Mar 13, 2024	Substantially Equivalent	BioPoly, LLC
K231188	ALIGN Radial Head System	Sep 28, 2023	Substantially Equivalent	Skeletal Dynamics, Inc.
K213563	DePuy Synthes Radial Head Replacement System	Mar 18, 2022	Substantially Equivalent	DePuy Synthes
K212872	Avenger Radial Head System	Dec 17, 2021	Substantially Equivalent	In2bones USA, LLC
K192754	Avenger Radial Head System	Jan 07, 2020	Substantially Equivalent	In2bones USA, LLC
K183618	Revolution Radial Head	May 17, 2019	Substantially Equivalent	Ignite Orthopedics, Inc.
K172688	Align Radial Head System	Dec 22, 2017	Substantially Equivalent	Skeletal Dynamics, LLC
K132735	AXIA RADIAL HEAD SYSTEM	Jan 07, 2014	Substantially Equivalent	Imds (Innovative MEdical Device Systems) - Leis ME
K131845	ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC	Sep 30, 2013	Substantially Equivalent	Acumed, LLC
K112030	SYNTHES RADIAL HEAD PROSTHESIS SYSTEM	Jun 19, 2012	Substantially Equivalent	Synthes USA, LLC
K092721	ALIGN RADIAL HEAD SYSTEM	Aug 03, 2010	Substantially Equivalent	Skeletal Dynamics, LLC
K062898	SBI LATERAL RHEAD IMPLANT	Nov 13, 2006	Substantially Equivalent	Small Bone Innovations, Inc.
K060731	EVOLVE MODULAR RADIAL HEAD	Apr 19, 2006	Substantially Equivalent	Wrightmedicaltechnologyinc
K051385	EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE	Aug 05, 2005	Substantially Equivalent	Biomet, Inc.
K041858	ACUMED ANATOMIC RADIAL HEAD SYSTEM	Oct 05, 2004	Substantially Equivalent	Acumed, LLC
K040611	MODULAR RADIAL HEAD REPLACEMENT DEVICE	Jun 04, 2004	Substantially Equivalent	Biomet, Inc.
K032806	KATALYST RADIAL HEAD IMPLANT	Apr 16, 2004	Substantially Equivalent	Kinetikos Medical, Inc.
K032686	ASCENSION MODULAR RADIAL HEAD	Oct 22, 2003	Substantially Equivalent	Ascension Orthopedics, Inc.
K030237	KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT	Aug 29, 2003	Substantially Equivalent	Kapp Surgical Instrument, Inc.
K030384	EVOLVE CERAMIC RADIAL HEAD IMPLANT	Aug 12, 2003	Substantially Equivalent	Wrightmedicaltechnologyinc
K023604	MODIFICATION TO RADIAL HEAD IMPLANT	Nov 27, 2002	Substantially Equivalent	Avanta Orthopaedics, Inc.
K012551	LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE	Jan 30, 2002	Substantially Equivalent	Biomet, Inc.
K011819	RADIAL HEAD IMPLANT	Jun 19, 2001	Substantially Equivalent	Avanta Orthopaedics, Inc.
K002644	RADIAL HEAD IMPLANT	Nov 20, 2000	Substantially Equivalent	Avanta Orthopaedics, Inc.
K994041	TORNIER BIPOLAR RADIAL HEAD PROSTHESIS	Aug 31, 2000	Substantially Equivalent	Tornier, Inc.
K001385	HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS	Jul 27, 2000	Substantially Equivalent	Howmedica Osteonics Corp.
K000658	ERS RADIAL HEAD REPLACEMENT	May 11, 2000	Substantially Equivalent	DePuy Orthopaedics, Inc.
K992220	RADIAL HEAD PROSTHESIS	Feb 25, 2000	Substantially Equivalent	Smith & Nephew, Inc.
K991915	MODULAR RADIAL HEAD	Sep 03, 1999	Substantially Equivalent	Wrightmedicaltechnologyinc
K984290	IMPLEX RADIAL HEAD REPLACEMENT SYSTEM	Jun 01, 1999	Substantially Equivalent	Implex Corp.
K982288	RADIAL HEAD IMPLANT	Sep 08, 1998	Substantially Equivalent	Avanta Orthopaedics, Inc.
K944507	METALLIC RADIAL HEAD IMPLANTS	Jul 13, 1995	Substantially Equivalent for Some Indications	Wrightmedicaltechnologyinc
K885146	CL UNIVERSAL HIP DEVICE	Apr 24, 1989	Substantially Equivalent	Lima Intl. Corp.