Who is the manufacturer of PRESS-FIT HIP STEM?

Encore Orthopedics, Inc. filed the 510(k) submission for PRESS-FIT HIP STEM (K964178).

What is the FDA product code for PRESS-FIT HIP STEM?

LWJ. It is classified under 21 CFR 888.3360 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for PRESS-FIT HIP STEM?

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

Who can help prepare an FDA 510(k) submission like PRESS-FIT HIP STEM?

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.

PRESS-FIT HIP STEM

K964178 · Encore Orthopedics, Inc. · LWJ · May 5, 1997 · Orthopedic

Device Facts

Record ID	K964178
Device Name	PRESS-FIT HIP STEM
Applicant	Encore Orthopedics, Inc.
Product Code	LWJ · Orthopedic
Decision Date	May 5, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3360
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Foundation® Press-Fit Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. It is intended to be used press-fit.

Device Story

Foundation® Press-Fit Hip Stem; femoral component for total hip arthroplasty. Trapezoidal proximal body; conical distal stem with flutes for rotational stability; coronal slot for stiffness reduction. Features Morse taper for modular heads; 132° neck/stem angle. Implanted via press-fit technique by orthopedic surgeons in hospital setting. Provides stable femoral fixation; restores joint function; alleviates pain associated with degenerative or traumatic hip conditions.

Clinical Evidence

Bench testing only; laboratory testing conducted on Morse type taper.

Technological Characteristics

Material: wrought/forged Ti-6Al-4V; proximal plasma-sprayed surface for fixation. Geometry: trapezoidal proximal body, conical distal stem, 132° neck/stem angle. Features: distal flutes, coronal slot, Morse taper. Sterilization: not specified.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, femoral neck fracture, or revision arthroplasty with minimal bone loss.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Related Devices

K973809 — FOUNDATION FRACTURE STEM · Encore Orthopedics, Inc. · Jan 2, 1998
K991325 — MODIFICATION OF ENCORE LINEAR POROUS COATED HIP · Encore Orthopedics, Inc. · Jun 25, 1999
K141001 — ALPINE HIP STEM; ALPINE HA HIP STEM · Ortho Development · Jul 30, 2014
K192236 — Fitmore Hip Stem · Zimmer GmbH · Nov 5, 2019
K961890 — FOUNDATION 9MM FORGED CEMENTED STEM · Encore Orthopedics, Inc. · Jun 14, 1996

Submission Summary (Full Text)

{0} K964178 # Summary of Safety and Effectiveness Encore Orthopedics®, Inc. 8900 Shoal Creek Blvd. Building 300 Austin, TX 78757 512-795-8696 MAY - 5 1997 **Trade Name:** Foundation® Press-Fit Hip Stem **Common Name:** Press-fit hip stem **Classification Name:** Hip joint metal/polymer semi-constrained prosthesis **Description:** The proximal body is trapezoidal in cross-sectional geometry. The distal stem portion is conical in shape and has flutes to provide rotational stability. A coronal slot in the larger stems decreases implant stiffness. The stem is available with and without a calcar collar and has a Morse type taper to receive modular heads. The neck/stem angle is 132°. The Foundation® Press-Fit Hip Stem is fabricated from wrought/forged Ti-6Al-4V. The proximal body of the stem has a plasma sprayed surface to enhance press-fit fixation. **Intended Use:** The Foundation® Press-Fit Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. It is intended to be used press-fit. **Comparable Features to Predicate Device(s):** Features comparable to predicate devices include Ti-6Al-4V substrate, straight stem, symmetric, calcar collar, no collar, distal fluted stem, modular heads and distal coronal slot.. **Test Results:** Laboratory testing of the Morse type taper was conducted.