Who is the manufacturer of IMPLEX CERAMIC HEAD?

Implex Corp. filed the 510(k) submission for IMPLEX CERAMIC HEAD (K955117).

What is the FDA product code for IMPLEX CERAMIC HEAD?

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

What is the regulatory pathway for IMPLEX CERAMIC HEAD?

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

Who can help prepare an FDA 510(k) submission like IMPLEX CERAMIC HEAD?

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.

IMPLEX CERAMIC HEAD

Q: What are the predicate devices for IMPLEX CERAMIC HEAD?

Modular Ceramic Heads from Biomet, Inc. (K925345); Zr Ceramic Heads from Howmedica (K952418); Zr Ceramic Heads from Howmedica (K946026).

K955117 · Implex Corp. · LZO · Apr 5, 1996 · Orthopedic

Device Facts

Record ID	K955117
Device Name	IMPLEX CERAMIC HEAD
Applicant	Implex Corp.
Product Code	LZO · Orthopedic
Decision Date	Apr 5, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3353
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Implex Ceramic Head is intended to provide articulation in cases of: 1. Severely disabled joints as a result of degenerative arthritis or avascular necrosis. 2. Secondary revision of a previously unsuccessful femoral component or total hip replacement. 3. Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results. 4. Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be obtained. 5. Non-union of femoral neck or head fractures. 6. Salvage of a failed primary or secondary total or hemi hip. The Implex Ceramic Head is intended to be used in either cemented or uncemented applications depending on the intended use of the femoral stem it is mated with.

Device Story

Implex Ceramic Head is a zirconia ceramic femoral head component for total hip replacement; spherical shape with tapered bore. Used in orthopedic surgery to reconstruct hip joint articulation; mates with femoral stem and acetabular cup. Provides joint spacing; supports both cemented and uncemented applications. Benefits patients by restoring joint function in cases of severe degeneration, fracture, or revision. Surgeon-operated in clinical/OR setting.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the established history of zirconia ceramic as an implant material and design similarity to predicate devices.

Technological Characteristics

Material: Zirconia ceramic. Form factor: Spherical femoral head with tapered bore. Dimensions: 28mm outer diameter; +0mm and +6mm neck lengths. Application: Cemented or uncemented hip arthroplasty.

Indications for Use

Indicated for patients with severely disabled hip joints due to degenerative arthritis or avascular necrosis, secondary revision of failed hip replacements, fracture dislocation, irreducible hip fractures, non-union of femoral neck/head fractures, or salvage of failed primary/secondary hip arthroplasty.

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

Modular Ceramic Heads from Biomet, Inc. (K925345)
Zr Ceramic Heads from Howmedica (K952418)
Zr Ceramic Heads from Howmedica (K946026)

Reference Devices

PROZYR™ Zirconium Oxide Ceramic Head from Smith & Nephew Richards, Inc.
Ceramic Bearing Head from Osteonics, Corp.

Related Devices

K013989 — ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER · Smith & Nephew, Inc. · Dec 19, 2001
K965002 — ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND · Encore Orthopedics, Inc. · Jun 27, 1997
K964150 — WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD · Whiteside Biomechanics, Inc. · Dec 27, 1996
K971414 — ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS · Smith & Nephew, Inc., Orthopaedic Div. · Jul 16, 1997
K971721 — WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD · Whiteside Biomechanics, Inc. · Jul 30, 1997

Submission Summary (Full Text)

{0} 04/02/96 15:45 FAX 1 800 371 7539 FAX IMPLEX CORP 002 R 955117 510(k) Summary of Safety and Effectiveness Implex Corp. Ceramic Head 510(K) Page 21 K955117 Submitter: Implex Corp. 80 Commerce Drive Allendale, NJ 07401-1600 Phone: 201/818-1800 FAX: 201/818-0567 Contact: James E. Malayter Date of Summary: 11/8/95 Product: Classification Name: Ceramic Femoral Head Component of Hip Joint, Metal/Ceramic/Polymer, Semi-constrained Cemented or Non-Porous Uncemented Prosthesis (21 CFR 888.3353) Generic Name: Ceramic Femoral Head Component of a Total Hip Replacement Trade/Proprietary Name: Implex Ceramic Head Substantially Equivalent Products: PROZYR™ Zirconium Oxide Ceramic Head from Smith & Nephew Richards, Inc. Ceramic Bearing Head from Osteonics, Corp. Modular Ceramic Heads from Biomet, Inc. (K925345) Zr Ceramic Heads from Howmedica (K952418 & K946026) Description: The Implex Ceramic Head is a ceramic femoral head. It is a spherical ball made from zirconia ceramic which has a tapered bore on one end of it. It is provided in one external diameter (28mm) and two (2) neck lengths (+0 Short, +6 Standard). Intended Use: The Implex Ceramic Head is intended to provide articulation in cases of: 1. Severely disabled joints as a result of degenerative arthritis or avascular necrosis. 2. Secondary revision of a previously unsuccessful femoral component or total hip replacement. 3. Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results. 4. Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be obtained. 5. Non-union of femoral neck or head fractures. 6. Salvage of a failed primary or secondary total or hemi hip. {1} 04/02/96 15:45 FAX 1 800 371 7539 FAX IMPLEX CORP 003 Implex Corp. Ceramic Head 510(K) Page 22 The Implex Ceramic Head is intended to be used in either cemented or uncemented applications depending on the intended use of the femoral stem it is mated with. ## Comparison to Substantially Equivalent Products: All of the named ceramic heads use Zirconia ceramic materials. These materials have a history of demonstrated success as implant materials for femoral heads. The Implex Ceramic Head is available in an outer diameter of 28mm and neck lengths of +0mm and +6mm. The other heads have outer diameters of 26mm, 28mm and 32mm and neck lengths of -5mm, -3mm, 0mm, +3mm, +4mm, +5mm, +6mm and +8mm. All of the named ceramic heads are used to reconstruct the hip joint in combination with femoral stem and acetabular cup to provide appropriate joint spacing and femoral/acetabular articulation. In addition, all of the products are intended to be used in cemented or cementless applications. All of the named ceramic heads are spherical, with a tapered bore manufactured in one end.