← Product Code [KWA](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA) · K031963 # CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD (K031963) _Wrightmedicaltechnologyinc · KWA · Oct 31, 2003 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K031963 ## Device Facts - **Applicant:** Wrightmedicaltechnologyinc - **Product Code:** [KWA](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA.md) - **Decision Date:** Oct 31, 2003 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3330 - **Device Class:** Class 3 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The CONSERVE® Plus Spiked Shells and CONSERVE® Total 56mm Femoral Head are 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; and, 4. revision procedures where other treatments or devices have failed. The CONSERVE® Plus Spiked Shells and CONSERVE® Total 56mm Femoral Head are intended for single patient use only. ## Device Story Metal-on-metal hip arthroplasty components; includes spiked acetabular shell and 56mm femoral head. Used in total hip replacement surgery to reconstruct acetabulum and replace femoral head. Spiked shell enhances fixation; femoral head utilizes WMT12/14 taper connection for compatibility with existing femoral stems. Operated by orthopedic surgeons in clinical/OR settings. Provides mechanical articulation to restore hip function and reduce pain in patients with degenerative joint disease or deformity. ## Clinical Evidence No clinical data provided; substantial equivalence supported by materials data and bench testing. ## Technological Characteristics Materials: Cast cobalt-chromium-molybdenum (ASTM F75). Acetabular shell: porous coated with CoCrMo sintered beads, 36-56mm ID, 3.5/4.5mm thickness. Femoral head: 56mm size, neck lengths -3.5, 0, +3.5. Articulating surfaces superfinished. WMT12/14 taper connection. ## Regulatory Identification A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027). ## Predicate Devices - Metal TRANSCEND® Articulation Monoblock Shell - Metal TRANSCEND® Femoral Head (Larger Sizes) ## 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}------------------------------------------------ Ko31963 p.1/2 # OCT 3 1 2003 # 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the CONSERVE® Plus Spiked Shell and CONSERVE® Total 56mm Femoral Head. Submitted Bv: Date: Contact Person: Proprietary Name: Common Name: Classification Name and Reference: Wright Medical Technology, Inc. June 23, 2003 Katie Logerot Regulatory Affairs Associate CONSERVE® Plus Spiked Shell and CONSERVE® Total 56mm Femoral Head Spiked Acetabular Shell and Femoral Head 21 CFR 888.3320 Hip joint metal/ metal semiconstrained, with a cemented acetabular component prosthesis - Class III 21 CFR 888.3330 Hip joint metal/ metal semiconstrained, with an uncemented acetabular component prosthesis - Class III Device Product Code and Panel Code: Orthopedics/87/KWA Orthopedics/87/JDL #### DEVICE INFORMATION #### A. INTENDED USE The CONSERVE® Plus Spiked Shells and CONSERVE® Total 56mm Fernoral Head are 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; - inflammatory degenerative joint disease such as theumatoid arthritis; 2. - 3. correction of functional deformity; and, - 4. revision procedures where other treatments or devices have failed headquarters Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901,867.9971 phone www.wmt.com International subsidiaries 011,32,2,378.3905 Belglum 011.39.0250.678.227 Italy 905.826.1600 Canada 011.81.3.3538.0474 Japan 011.33.1.45.13.24.40 France 011.44.1483.721.404 UK 011.49.4161.745130 Germany {1}------------------------------------------------ # KO31963 The CONSERVE® Plus Spiked Shells and CONSERVE® Total 56mm Femoral Head are intended for single patient use only. ## B. DEVICE DESCRIPTION The design features of the CONSERVE® Plus Spiked Shell are summarized below: - Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75 - Porous coated with CoCrMo (ASTM F75) Sintered beads - Available sizes: 36mm-56mm ID; available in two shell thicknesses 3.5mm and ● 4.5mm - . The articulating surface of the implants will be superfinished to insure form tolerance and a fine surface finish - A one-piece acetabular shell allows the surgeon to reconstruct the acetabulum while ● removing very little bone to accommodate a larger Femoral Head - Spikes are added to the outer surface to enhance fixation . The design features of the CONSERVE® Total 56mm Femoral Head are summarized below: - Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75 ● - Available size: 56mm . - Available neck lengths: -3.5, 0, +3.5 ● - The articulating surface of the implants will be superfinished to insure form tolerance ● and a fine surface finish - The taper connection for the CONSERVE® Total 56mm Femoral Head will be . identical to the Metal TRANSCEND® Femoral Heads Larger Sizes and is intended to be used with our existing femoral stems manufactured with WMT12/14 taper. ### C. SUBSTANTIAL EQUIVALENCE INFORMATION The intended use, material, and type of interface of the CONSERVE® Plus Spiked Shells are identical to the Metal TRANSCEND® Articulation Monoblock Shell. The design features are identical with the exception of additional spikes, a thinner wall, and a larger size offering. The CONSERVE® Total 56mm Femoral Head is a size addition to the Metal TRANSCEND® Femoral Head (Larger Sizes). The design features of the CONSERVE® Total 56mm Femoral Head are identical to the design features of the Metal TRANSCEND® Femoral Head (Larger Sizes). The safety and effectiveness of this device are adequately supported by the substantial equivalence information, materials data, testing results, and clinical data provided within this Premarket Notification. Image /page/1/Picture/19 description: The image shows a black and white graphic that appears to be a partial view of a globe or planet. The upper portion of the image features a textured, circular shape, possibly representing land or geographical features. A curved line is visible above the circular shape, suggesting an atmospheric layer or the edge of the planet. At the bottom of the image, there is some illegible text, which seems to be a label or caption associated with the graphic. Image /page/1/Picture/20 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, sans-serif font. Below the word "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font, underlined by a thin line. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 3 1 2003 Ms. Katie Logerot Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road, Arlington, Tennessee 38002 Re: K031963 Trade/Device Name: CONSERVE® Plus Spiked Shell and CONSERVE® Total 56mm Femoral Head Regulation Number: 21 CFR 888.3320 and 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Code: KWA and JDL Dated: September 30, 2003 Received: October 1, 2003 Dear Ms. Logerot: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Ms. Katie Logerot This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Mark N. Mulkerson Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K031963 Image /page/4/Picture/1 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a graphic of three stylized, overlapping shapes that resemble wings or feathers. The letters are large and spaced closely together, creating a strong visual impact. The graphic element adds a sense of movement and dynamism to the logo. # CONSERVE® Plus Spiked Shell and CONSERVE® Total 56mm Femoral Head #### INDICATIONS STATEMENT The CONSERVE® Plus Spiked Shells and CONSERVE® Total 56mm Femoral Head are 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; and, - 4. revision procedures where other treatments or devices have failed The CONSERVE® Plus Spiked Shells and CONSERVE® Total 56mm Femoral Head are intended for single patient use only. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per21 CFR 801.109) OR Over-The Counter Use (Optional Format 1-2-96) Division of General Restorative Devices R. Mark N. Milken eral. Rest rative ical Devices 510(k) Number ***_*** K031963 (Division Sign-Off) 510(k) Number headquarters Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 36002 901.867.9971 phone www.wmt.com international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy 905,826.1600 Canada 011.81.3.3538.0474 Japan 011.33.1.45.13.24.40 France 011.44.1483.721.404 UK 011.49.4161.745130 Germany --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K031963](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWA/K031963) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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