← Product Code [LPH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH) · K050937 # TRABECULAR METAL ACETABULAR REVISION SHELLS (K050937) _Zimmer Trabecular · LPH · May 11, 2005 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K050937 ## Device Facts - **Applicant:** Zimmer Trabecular - **Product Code:** [LPH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH.md) - **Decision Date:** May 11, 2005 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3358 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Indications for Use of the Trabecular Metal Acetabular Revision Shells are: - For cemented or cementless use. - Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis or late stage avascular necrosis. - Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. - Clinical management problem where arthrodesis or alternative reconstruction techniques are less likely to achieve satisfactory results. - Where bone stock is of poor quality or is inadequate for reconstructive techniques as indicated by other deficiencies of the acetabulum. ## Device Story Modular acetabular reconstructive device; used in primary or revision hip procedures. Composed of Trabecular Metal porous tantalum; features Ti-6Al-4V instrument interface ring (ASTM F-136) for impaction. Implanted via cementless or cemented fixation; includes screwholes for optional ancillary fixation using Zimmer 6.5mm titanium alloy bone screws. Polyethylene liner cemented to shell. Used by orthopedic surgeons in clinical/OR settings to restore acetabular function in patients with poor bone stock or failed prior arthroplasty. ## Clinical Evidence Bench testing only. ## Technological Characteristics Modular acetabular shell; porous tantalum material; Ti-6Al-4V instrument interface ring (ASTM F-136); compatible with 6.5mm titanium alloy bone screws; cemented or cementless fixation; polyethylene liner interface. ## Regulatory Identification A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement. ## 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}------------------------------------------------ ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS K050937 page 1 of 2 ## The Trabecular Metal Acetabular Revision Shells | Submitter Name: | Zimmer Trabecular Metal Technology, Inc. | |------------------------|-------------------------------------------------------| | Submitter Address: | 80 Commerce Drive
Allendale, New Jersey 07401-1600 | | Contact Person: | Marci Halevi | | Phone Number: | (201) 818-1800 ext. 507 | | Fax Number: | (973) 879-0825 | | Date Prepared: | April 11, 2005 | | Device Trade Name: | The Trabecular Metal Acetabular Revision Shell | | Device Common Name: | Acetabular revision shells or cages | | Classification Number: | 21 CFR § 888.3358 and 21 CFR § 888.3350 | The term "substantial equivalence" as used in this 510(k) Substantial notification is limited to the definition of substantial equivalence Equivalence: found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or A determination of substantial equivalency reclassification. under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts. - The Trabecular Metal Acetabular Revision Shell is a modular Device Description: acetabular reconstructive device (polyethylene liner is cemented to shell) intended for use in primary or revision reconstructive procedures of the acetabulum. The subject Trabecular Metal Acetabular Revision Shell is manufactured from Trabecular Metal porous tantalum. The TM Revision Shell has a Ti-6A1-4V instrument interface ring (ASTM F-136) along its outer perimeter that provides a rigid contact area for the impaction instrument used to implant the device. The Revision Shells are intended for either cementless or cemented fixation to the acetabulum with that allow for optional ancillary fixation to the acetebulum. The screwholes mate with commercially available Zimmer 6.5mm titanium allov bone screws. {1}------------------------------------------------ **510(k) Summary (Continued)** ## The Indications for Use of the Trabecular Metal Acetabular Indications for Use: Revision Shells are: - For cemented or cementless use. . - Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis or late stage avascular necrosis. - Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. - Clinical management problem where arthrodesis or . alternative reconstruction techniques are less likely to achieve satisfactory results. - Where bone stock is of poor quality or is inadequate for 1 reconstructive techniques as indicated by other deficiencies of the acetabulum. The Trabecular Metal Acetabular Revision Shells are Conclusion: substantially equivalent to the identified predicate devices. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem of three stylized lines, resembling a bird in flight, which is the department's symbol. Public Health Service MAY 1 1 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Marci Halevi Manager of Regulatory Affairs Zimmer Trabecular Metal Technology 80 Commerce Drive Allendale, New Jersey 07401-1600 Re: K050937 Trade/Device Name: Trabecular Metal Acetabular Revision Shells Regulation Number: 21 CFR 888.3358, 888.3350 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented I up Joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: LPH, JDI Dated: April 11, 2005 Received: April 14, 2005 Dear Ms. Halevi: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your section 910(t) production is substantially equivalent (for the indications for referenced above and nave decommised are as a seed predicate devices marketed in interstate commerce use stated in the encrosure/ to regary into of the Medical Device Amendments, or to devices that prior io May 26, 1770, the chaomistic and the provisions of the Federal Food, Drug, and Cosmetic liave been reclassified in accordines was a premarket approval application (PMA). You may, Act (Act) that do not require approval othe general controls provisions of the Act. The general therefore, market the device, subject to an igent of annual registration, listing of devices, good controls provisions of alleling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Sec ao ve) into existing major regulations affecting your device can be illiay be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish found in the South ents concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri-s issualled of a with other requirements of the Act of that FDA made a decemination that your ceviler Federal agencies. You must comply with any Federal Statutes and regulations administration of to: registration and listing (21 CFR Part 807); all the Act s requirements, including, but novine weeks as set forth in the quality labeling (21 CFR Part 0017, good manager, and if applicable, the electronic product radiation systems (QB) regalates (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Ms. Marci Halevi This letter will allow you to begin marketing your device as described in your Section 510(k) This letter while anow you to begin matical equivalence of your device to a legally premarket notification. The PDA mining or castimation 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 If you desire specific at not 2017 - 1 240) 276-0120. Also, please note the regulation entitled, Contact the Office of Commarket notification" (21CFR Part 807.97) you may obtain. Misoranting by reference to premarismonsibilities under the Act may be obtained from the Oiler general mionmation on your resmational 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/industry/support/index.html Sincerely yours, Stupt Rhodes Miriam Provost, Ph.D. Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Zimmer Trabecular Metal Technology, Inc. 510(k) Number (if known): K05-0937 Device Name: Trabecular Metal Acetabular Revision Shells Indications For Use: The Indications for Use of the Trabecular Metal Acetabular Revision Shells are: - For cemented or cementless use. . - For Cemented of Cementioso aco: Painful, disabling joint disease of the hip resulting from: degenerative arthritis, a rheumatoid arthritis or late stage avascular necrosis. - medifiation of previous unsuccessful femoral head replacement, cup arthroplasty . or other procedure. - of other procedure. " techniques are less likely to achieve satisfactory results. Where bone stock is of poor quality or is inadequate for other Where "bons" econniques as indicated by deficiencies of the acetabulum. Prescription Use (Per 21 CFR 801 Subpart D) AND/OR. . . Over - The -Counter Use No (21 CFR 801 Subpart C) (Optional Format 09-2004) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH; Office of Device Evaluation (ODE) Htyt Edwards ral. Restorative. and Neurologic 510(k) N --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K050937](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K050937) **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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