Who is the manufacturer of THE C-FIT FEMORAL HIP SYSTEM?

Corin USA filed the 510(k) submission for THE C-FIT FEMORAL HIP SYSTEM (K965019).

What is the FDA product code for THE C-FIT FEMORAL HIP SYSTEM?

JDI. It is classified under 21 CFR 888.3350 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for THE C-FIT FEMORAL HIP SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for THE C-FIT FEMORAL HIP SYSTEM?

V.S.P. (C-Fit stem) Hip system (Corin Medical Ltd.).

Who can help prepare an FDA 510(k) submission like THE C-FIT FEMORAL HIP SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

THE C-FIT FEMORAL HIP SYSTEM

K965019 · Corin USA · JDI · Mar 25, 1997 · Orthopedic

Device Facts

Record ID	K965019
Device Name	THE C-FIT FEMORAL HIP SYSTEM
Applicant	Corin USA
Product Code	JDI · Orthopedic
Decision Date	Mar 25, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3350
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The devices are used to resurface the femoral hip joint and reconstitute function following the degenerative effects of osteo and rheumatoid arthritis, post trauma disease effects, avascular necrosis and septic or aseptic total hip revision. The C-Fit plasma sprayed femoral components are intended for use with bone cement only.

Device Story

Femoral hip system; includes standard and long stem options; optional calcar collars; plasma-sprayed cobalt chrome coating for mechanical interlock with PMMA bone cement. Manufactured from cobalt chrome alloy. Used in orthopedic surgery to resurface femoral hip joint; reconstitutes function post-degeneration. Compatible with Corin cobalt chrome modular heads, bipolar, or uni-polar devices. Intended for cemented use only. Surgeon-operated in clinical/OR setting; provides structural support for hip joint; improves patient mobility/function.

Clinical Evidence

No clinical trials presented. Device has approximately 10 years of clinical use outside the U.S. with no reported significant post-operative problems. Safety supported by extensive mechanical bench testing.

Technological Characteristics

Materials: Cobalt chrome alloy stem with cobalt chrome plasma spray coating. Design: Standard and long stem options, with/without calcar collars. Intended for use with PMMA bone cement. Mechanical interlock via increased surface roughness from plasma spray.

Indications for Use

Indicated for patients requiring femoral hip joint resurfacing due to osteoarthritis, rheumatoid arthritis, post-traumatic disease, avascular necrosis, or septic/aseptic total hip revision.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

V.S.P. (C-Fit stem) Hip system (Corin Medical Ltd.)

Reference Devices

Mallory/head system (Biomet)

Related Devices

K191056 — Conformity stem, cemented · United Orthopedic Corporation · Jan 3, 2020
K980794 — DUAL LOCK HIP STEM · Depuy, Inc. · May 20, 1998
K960658 — COLLARLESS POLISHED TAPER HIP PROSTHESIS · Zimmer, Inc. · Jul 16, 1996
K954598 — OSTEONICS OFFSET HIP STEMS · Osteonics Corp. · Apr 4, 1996
K992058 — BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM · Biomet, Inc. · Jul 1, 1999

Submission Summary (Full Text)

{0} Page 8 K965019 # 510(k) SUMMARY MAR 25 1997 **Name of Company:** Corin Medical Ltd. The Corinium Centre Cirencester Gloucestershire GL7 1YJ United Kingdom **Name of Device:** The C-Fit Femoral Hip System **Device Description:** A femoral hip system consisting of standard and long stem options with or without calcar collars, plasma sprayed either proximally or five eighths of stem and for use with or without a PMMA cement centralizer. The devices are used to resurface the femoral hip joint and reconstitute function following the degenerative effects of osteo and rheumatoid arthritis, post trauma disease effects, avascular necrosis and septic or aseptic total hip revision. The femoral stems are manufactured from cobalt chrome alloy. The cobalt chrome plasma spray coating provides an increased surface roughness to act as key for mechanical interlock with PMMA bone cement. The stem devices may be used with any one of a range of previously cleared Corin cobalt chrome modular heads, bipolar or uni-polar modular devices. The C-Fit plasma sprayed femoral components are intended for use with bone cement only. ## SUMMARY OF SUBSTANTIAL EQUIVALENCE AND SAFETY AND EFFECTIVENESS The C-Fit Femoral Hip system is a modification of the previously cleared V.S.P. (now called C-Fit stem) Hip system, manufactured by Corin Medical Ltd. The original V.S.P. (now called C-Fit stem) stem is manufactured from titanium alloy with a cobalt chrome plasma spray coating applied. This submission extends the range to include a cobalt chrome stem with cobalt chrome plasma spray coating and long stem options. The C-Fit cobalt chrome stem without coating is previously cleared for sale for use with cement. Corin, additionally, claims substantial equivalence to the Mallory/head system from Biomet, with the specific reference to plasma sprayed long femoral stems. This submission is supported by extensive mechanical test data confirming the device’s safety and effectiveness. The device has been in clinical use outside the U.S. for approximately ten years and no significant post-operative problems have been reported.