Who is the manufacturer of RELIANCE PF FEMORAL STEMS?

Howmedica Corp. submitted the Traditional clearance for RELIANCE PF FEMORAL STEMS (K970200).

What is the FDA product code for RELIANCE PF FEMORAL STEMS?

LZO. It is classified under 21 CFR 888.3353 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for RELIANCE PF FEMORAL STEMS?

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

RELIANCE PF FEMORAL STEMS

Q: What are the predicate devices for RELIANCE PF FEMORAL STEMS?

HNR Hip System (K903563); DRG Femoral component (K936126); Premium Femoral Component (K936127); McCutchen Hip System (Dow Corning Wright).

K970200 · Howmedica Corp. · LZO · Apr 9, 1997 · Orthopedic

Device Facts

Record ID	K970200
Device Name	RELIANCE PF FEMORAL STEMS
Applicant	Howmedica Corp.
Product Code	LZO · Orthopedic
Decision Date	Apr 9, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3353
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Reliance® PF stem is a femoral component of a Total Hip System. It is intended to be used for primary or secondary reconstruction of the proximal femur damaged as a result of inflammatory, non-inflammatory, or traumatic joint disease. The Reliance® PF stem is intended to be used in conjunction with Howmedica's V40 femoral heads, Acetabular components, and unipolar and bipolar components. The stem can be press-fit into the proximal femur for fixation by mechanical interlock, or affixed with bone cement.

Device Story

Reliance® PF Femoral Stem; metallic hip prosthesis component. Used for primary/secondary proximal femur reconstruction. Operates via press-fit mechanical interlock or bone cement fixation. Used in conjunction with V40 femoral heads, acetabular components, and unipolar/bipolar components. Physician-operated in surgical setting. Provides structural replacement for damaged hip joint; restores joint function.

Clinical Evidence

Bench testing only. Endurance load testing demonstrated performance exceeding the Semlitsch minimum of 630 lbs.

Technological Characteristics

Material: Forged cobalt-chromium-molybdenum (Vitallium®) alloy. Design: Femoral stem for total hip arthroplasty. Fixation: Press-fit (mechanical interlock) or cemented. Energy source: None (mechanical).

Indications for Use

Indicated for primary or secondary reconstruction of proximal femur damaged by inflammatory, non-inflammatory, or traumatic joint disease.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

HNR Hip System (K903563)
DRG Femoral component (K936126)
Premium Femoral Component (K936127)
McCutchen Hip System (Dow Corning Wright)

Related Devices

K032110 — PROCLASS PRESS FIT HIP STEM · Stelkast Company · Sep 22, 2003
K980813 — RELIANCE LONG STEM FEMORAL COMPONENTS · Howmedica, Inc. · Jun 26, 1998
K001984 — PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT · Stelkast Company · Sep 27, 2000
K053293 — ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS · Ortho Development Corp. · Feb 16, 2006
K141001 — ALPINE HIP STEM; ALPINE HA HIP STEM · Ortho Development · Jul 30, 2014

Submission Summary (Full Text)

{0} APR - 9 1997 510(k) Summary K970200 Proprietary Name: Reliance® PF Femoral Stems Common Name: Metallic Hip Stem Classification Name and Reference: 21 CFR 888.3353 Hip Joint Metal/Ceramic/Polymer semi-constrained cemented or nonporous uncemented prosthesis. Proposed Regulatory Class: Class II Device Product Code: LZO For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 Fax: (201) 507-6870 Date Summary Prepared: 1-17-97 The Reliance® PF stem is a femoral component of a Total Hip System. It is intended to be used for primary or secondary reconstruction of the proximal femur damaged as a result of inflammatory, non-inflammatory, or traumatic joint disease. The Reliance® PF stem is intended to be used in conjunction with Howmedica's V40 femoral heads, Acetabular components, and unipolar and bipolar components. The stem can be press-fit into the proximal femur for fixation by mechanical interlock, or affixed with bone cement. The Reliance® PF stem is manufactured from forged cobalt-chromium-molybdenum (Vitallium®) alloy. The substantial equivalence of the Reliance® PF stem is based on an equivalence in intended use, materials, design, operational principles, and relative indications and contraindications to Howmedica's HNR Hip System (K903563), DRG Femoral component (K936126), Premium Femoral Component (K936127), and Dow Corning Wright's McCutchen Hip System. Testing has demonstrated that the endurance load exceeds the Semlitsch minimum of 630 lbs.