← Product Code [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI) · K964218 # PERFECTA PLASMA SPRAY HIP STEM (K964218) _Wrightmedicaltechnologyinc · JDI · Jan 8, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K964218 ## Device Facts - **Applicant:** Wrightmedicaltechnologyinc - **Product Code:** [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI.md) - **Decision Date:** Jan 8, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3350 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The PERFECTA® Plasma Spray Hip System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. ## Device Story Plasma spray coated femoral hip stem; titanium alloy (ASTM F-136) construction; standard/reduced flare configurations; collared/collarless options. Used in total hip arthroplasty; press-fit or cemented implantation. Device provides structural support for hip joint; restores function; relieves pain. Used by orthopedic surgeons in clinical/OR settings. ## Clinical Evidence Bench testing only. Abrasion testing demonstrates plasma spray porous coating comparability to sintered bead coating. Validated finite element analysis confirms fatigue strength of worst-case subject device is comparable to predicate device. ## Technological Characteristics Material: Titanium alloy (ASTM F-136) with titanium plasma spray coating. Design: Femoral hip stem, standard/reduced flare, collared/collarless. Fixation: Press-fit or bone cement. No software or electronic components. ## Regulatory 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 - PERFECTA® Plasma Spray Hip System (Wright Medical Technology, Inc.) - PERFECTA® Revision Hip System (Wright Medical Technology, Inc.) ## 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} JAN 8 1997 K964218 WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE ROAD ARLINGTON, TN 38002 901-867-9971 Contact Person: Cristie Manuel Date: October 21, 1996 # 510(k) Summary Trade/Proprietary Name: PERFECTA® Plasma Spray Hip System Common Name: Plasma Spray Coated Femoral Hip Stem Classification: Class II Predicate Devices: PERFECTA® Plasma Spray Hip System and PERFECTA® Revision Hip System manufactured by Wright Medical Technology, Inc. This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. # Description/Intended Use The PERFECTA® Plasma Spray Hip System is manufactured from titanium alloy (ASTM F-136) with a titanium plasma spray coating. The stem is available in standard and reduced flare configurations, collared and collarless. The stem is designed to be press-fit or can be used with bone cement. The PERFECTA® Plasma Spray Hip System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. # Testing Submitted abrasion testing demonstrates that the plasma spray porous coating is comparable to sintered bead coating. Submitted validated finite element analysis indicates that the fatigue strength of the worst case subject device, the PERFECTA® 12mm reduced flare, collarless hip stem, is comparable to the fatigue strength of the predicate PERFECTA® 12mm calcar revision hip stem. 000145 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K964218](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K964218) **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. 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