← Product Code [LZO](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO) · K955117 # IMPLEX CERAMIC HEAD (K955117) _Implex Corp. · LZO · Apr 5, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K955117 ## Device Facts - **Applicant:** Implex Corp. - **Product Code:** [LZO](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO.md) - **Decision Date:** Apr 5, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3353 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## Regulatory 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](/device/K925345.md)) - Zr Ceramic Heads from Howmedica ([K952418](/device/K952418.md)) - Zr Ceramic Heads from Howmedica ([K946026](/device/K946026.md)) ## Reference Devices - PROZYR™ Zirconium Oxide Ceramic Head from Smith & Nephew Richards, Inc. - Ceramic Bearing Head from Osteonics, Corp. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K955117](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LZO/K955117) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com