Product Code: JDB FDA class 2 21 CFR 888.3160

Prosthesis, Elbow, Semi-Constrained, Cemented

Orthopedic

A semi-constrained cemented elbow prosthesis is an implantable joint replacement device that replaces the elbow articulation with linked metal and polymer components fixed with bone cement, allowing controlled range of motion while providing stability for patients with severe arthritis, trauma, or other elbow joint pathology. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JDB, regulated under 21 CFR 888.3160, within the Orthopedic medical specialty. This device is an implant.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: JDB
Device Class: FDA class 2
Regulation Number: 888.3160
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 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K222807	TEMA Elbow system - Line extension	Oct 26, 2022	Substantially Equivalent	Lima Corporate S.P.A.
K193247	LATITUDE EV Total Elbow Arthroplasty	Aug 05, 2020	Substantially Equivalent	Tornier, Inc.
K182461	LATITUDE EV Total Elbow Arthroplasty	Dec 27, 2018	Substantially Equivalent	Tornier, Inc.
K171010	Latitude EV Total Elbow Arthroplasty	Aug 31, 2017	Substantially Equivalent	Tornier, Inc.
K102180	RHEAD RADIAL HEAD EXTENDED STEMS	Dec 20, 2010	Substantially Equivalent	Small Bone Innovations, Inc.
K100562	LATITUDE ELBOW PROSTHESIS	Jun 29, 2010	Substantially Equivalent	Tornier, Inc.
K070787	LATITUDE ELBOW PROTHESIS	Aug 24, 2007	Substantially Equivalent	Tornier
K070236	SBI LATERAL RADIO CAPITELLUM	Feb 21, 2007	Substantially Equivalent	Small Bone Innovations, Inc.
K060438	RHS	Apr 18, 2006	Substantially Equivalent	Tornier
K060038	SBI RADIO-CAPITELLAR IMPLANT	Mar 30, 2006	Substantially Equivalent	Small Bone Innovations, Inc.
K050848	TORNIER ELBOW PROSTHESIS	Jul 14, 2005	Substantially Equivalent	Tornier
K031218	MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS	May 16, 2003	Substantially Equivalent	Tornier
K011567	TORNIER TOTAL ELBOW PROSTHESIS	Jun 19, 2001	Substantially Equivalent	Tornier
K983141	CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS	Nov 06, 1998	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K972691	ABC TOTAL ELBOW PROTHESIS	Oct 15, 1997	Substantially Equivalent	Biomet, Inc.
K960087	SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)	Sep 20, 1996	Substantially Equivalent	Wrightmedicaltechnologyinc
K955099	SORBIE TOTAL ELBOW SYSTEM	Feb 05, 1996	Substantially Equivalent	Wrightmedicaltechnologyinc
K880188	SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM	Mar 01, 1988	Substantially Equivalent	Howmedica Corp.
K873660	ROPER-TUKE ELBOW	Jan 06, 1988	Substantially Equivalent for Some Indications	Orthopedic Systems, Inc.
K823473	POROCOAT MARK IV ELBOW	Jan 20, 1983	Substantially Equivalent	Depuy, Inc.
K820957	SUFACE REPLACEMENT ELBOW	Jul 02, 1982	Substantially Equivalent	Howmedica Corp.
K812322	ARIZONA RADIO CAPITELLAR TOTAL ELBOW	Jan 04, 1982	Substantially Equivalent	Zimmer, Inc.
K811451	RADIAL HEAD PROSTHESIS	Jun 09, 1981	Substantially Equivalent	Cintor Orthopaedic Div.
K810847	PRITCHARD SURFACE REPLACEMENT ELBOW	May 01, 1981	Substantially Equivalent	Depuy, Inc.
K802348	TRIAXIAL	Feb 23, 1981	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K802460	HELFET ELBOW PROSTHESIS	Nov 19, 1980	Substantially Equivalent	Depuy, Inc.
K801574	DEPALMA ELBOW	Oct 31, 1980	Substantially Equivalent	Zimmer, Inc.