Who is the manufacturer of DEPUY ENDURANCE CALCAR HIP PROSTHESIS?

Depuy, Inc. filed the 510(k) submission for DEPUY ENDURANCE CALCAR HIP PROSTHESIS (K961619).

What is the FDA product code for DEPUY ENDURANCE CALCAR HIP PROSTHESIS?

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

What is the regulatory pathway for DEPUY ENDURANCE CALCAR HIP PROSTHESIS?

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

What are the predicate devices for DEPUY ENDURANCE CALCAR HIP PROSTHESIS?

DePuy Cemented Hip Stem (Endurance Hip Stem); DePuy AML Calcar Hip Prosthesis.

Who can help prepare an FDA 510(k) submission like DEPUY ENDURANCE CALCAR HIP PROSTHESIS?

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.

DEPUY ENDURANCE CALCAR HIP PROSTHESIS

K961619 · Depuy, Inc. · JDI · Jul 12, 1996 · Orthopedic

Device Facts

Record ID	K961619
Device Name	DEPUY ENDURANCE CALCAR HIP PROSTHESIS
Applicant	Depuy, Inc.
Product Code	JDI · Orthopedic
Decision Date	Jul 12, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3350
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Endurance Calcar Hip Prosthesis is indicated for cemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joint of patients whose hip joint has been damaged by inflammatory or non-inflammatory degenerative joint disease, fracture or the failure of a previous arthroplasty. The stem is especially suited to primary or revision cases where the calcar of the femur may be deficient and for cases of intertrochanteric fracture.

Device Story

Forged Co-Cr-Mo femoral stem for cemented total hip arthroplasty; features 2.25cm calcar platform for seating; available in one size, two lengths; design variation of existing Endurance hip stem with intermediate offset and no collar. Used by orthopedic surgeons in hospital settings for primary or revision hip replacement; addresses femoral calcar deficiency or intertrochanteric fractures. Provides structural replacement of hip joint; restores joint function.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarity to predicate devices.

Technological Characteristics

Material: Forged Co-Cr-Mo alloy. Design: Femoral stem with 2.25cm calcar platform, intermediate offset, collarless. Intended for cemented fixation. Class II device (21 CFR 888.3350).

Indications for Use

Indicated for patients requiring cemented total hip arthroplasty due to inflammatory/non-inflammatory degenerative joint disease, fracture, or failed previous arthroplasty. Specifically suited for primary or revision cases with deficient femoral calcar or intertrochanteric fractures.

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

DePuy Cemented Hip Stem (Endurance Hip Stem)
DePuy AML Calcar Hip Prosthesis

Related Devices

K954598 — OSTEONICS OFFSET HIP STEMS · Osteonics Corp. · Apr 4, 1996
K191056 — Conformity stem, cemented · United Orthopedic Corporation · Jan 3, 2020
K962002 — AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM · Exactech, Inc. · Aug 8, 1996
K992058 — BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM · Biomet, Inc. · Jul 1, 1999
K964704 — DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM · Depuy, Inc. · Jan 24, 1997

Submission Summary (Full Text)

{0} K961619 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS JUL 12 1996 NAME OF FIRM: DePuy Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 510(K) CONTACT: Cheryl Hastings Manager, Pre-clinical Device Evaluation TRADE NAME: Endurance Calcar Hip Prosthesis CLASSIFICATION: Hip prosthesis semi-constrained, metal/polymer, cemented (21 CFR 888.3350) DEVICE PRODUCT CODE: 87 JDI SUBSTANTIALLY EQUIVALENT DEVICES: DePuy Cemented Hip Stem (tradenamed the Endurance Hip Stem) DePuy AML Calcar Hip Prosthesis # DEVICE DESCRIPTION AND INTENDED USE: The Endurance Calcar Hip Prosthesis is a forged Co-Cr-Mo stem, available in one size and two stem lengths. The design of the stem is similar to the design of the size 3 DePuy Cemented Hip Stem (now called the Endurance hip stem) except that the Endurance Calcar has an offset that is midway between the standard and high offset Endurance stems, does not have a collar and does have a 2.25cm calcar platform which is used to seat the implant. The Endurance Calcar Hip Prosthesis is indicated for cemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joint of patients whose hip joint has been damaged by inflammatory or non-inflammatory degenerative joint disease, fracture or the failure of a previous arthroplasty. The stem is especially suited to primary or revision cases where the calcar of the femur may be deficient and for cases of intertrochanteric fracture. # BASIS OF SUBSTANTIAL EQUIVALENCE: The Endurance Calcar Hip Stem is similar to the Endurance Hip Stem in that they have the same basic design, are manufactured from the same material and are both intended for use in cemented total hip arthroplasty. The Endurance Calcar Hip Stem is similar to the AML Calcar Hip Stem in that both stems have calcar platforms, are intended for use in cemented total hip arthroplasty, and can be used in cases where the calcar of the femur is deficient. 000012