Product Code: JDO FDA class 2 21 CFR 888.3030

Device, Fixation, Proximal Femoral, Implant

Orthopedic

A proximal femoral fixation implant is an orthopedic device used to stabilize and repair fractures of the proximal femur, including intertrochanteric and subtrochanteric fractures, by providing internal fixation through screws, plates, or intramedullary nail systems anchored in the femoral bone. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is JDO, regulated under 21 CFR 888.3030, within the Orthopedic medical specialty. This device is an implant.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: JDO
Device Class: FDA class 2
Regulation Number: 888.3030
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 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K230764	OsteoCentric Integrated Hip Fastener System	Apr 18, 2023	Substantially Equivalent	OsteoCentric Technologies
K213126	Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws	Sep 29, 2022	Substantially Equivalent	Smith & Nephew, Inc.
K210247	OsteoCentric Integrated Hip Fastener System	Apr 30, 2021	Substantially Equivalent	Osteocentric Technologies D.B.A. Osteocentric Trauma
K193029	CONQUEST FN	Feb 28, 2020	Substantially Equivalent	Smith & Nephew, Inc.
K173826	THP Hip Fracture Plating System	Feb 07, 2018	Substantially Equivalent	Biomet, Inc.
K172785	CONQUEST FN	Dec 22, 2017	Substantially Equivalent	Smith & Nephew
K152686	CONQUEST FN	Mar 17, 2016	Substantially Equivalent	Smith & Nephew
K140018	TSP HIP FRACTURE PLATING SYSTEM	Apr 04, 2014	Substantially Equivalent	Biomet, Inc.
K080685	HIPLOC COMPRESSION HIP SCREW	Aug 15, 2008	Substantially Equivalent	Biomet Manufacturing, Inc.
K080434	INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW	Apr 10, 2008	Substantially Equivalent	Smith & Nephew, Inc.
K983814	GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM	Jan 14, 1999	Substantially Equivalent	Efratgo, Ltd. HI Tech Bio-Surgical
K981757	SYNTHES (USA) DHS HELIX SYSTEM	Jul 17, 1998	Substantially Equivalent	Synthes (Usa)
K964259	SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION	Jan 09, 1997	Substantially Equivalent	Synthes (Usa)
K962644	VIGOR COMPRESSION HIP SCREW SYSTEM	Sep 06, 1996	Substantially Equivalent	Deutschland Surgical, Inc.
K953607	TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS)	Mar 08, 1996	Substantially Equivalent	Synthes (Usa)
K951904	SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX]	Jul 17, 1995	Substantially Equivalent	Synthes (Usa)
K934161	PROFORM HIP SYSTEM	Mar 10, 1994	Substantially Equivalent	Stelkast Company
K934162	PROFORM HA HIP SYSTEM	Mar 09, 1994	Substantially Equivalent for Some Indications	Stelkast Company
K923613	SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT	Jun 22, 1993	Substantially Equivalent	Synthes (Usa)
K831076	COMPRESSION SYSTEM	Apr 28, 1983	Substantially Equivalent	Kirschner Medical Corp.
K810258	PROXIMAL FERMORAL HIP REPLACEMENT	Mar 05, 1981	Substantially Equivalent	Biomet, Inc.
K781389	BIOMET CONCENTRIC HEX SCREW	Aug 21, 1978	Substantially Equivalent	Biomet, Inc.
K780187	NAIL, MASSIE II	Mar 15, 1978	Substantially Equivalent	Howmedica Corp.