← Product Code [LPH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH) · K070369 # REGENERX RINGLOC + MODULAR ACETABULAR SHELLS (K070369) _Biomet, Inc. · LPH · Mar 9, 2007 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K070369 ## Device Facts - **Applicant:** Biomet, Inc. - **Product Code:** [LPH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH.md) - **Decision Date:** Mar 9, 2007 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3358 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use Cemented or non-cemented total hip replacement in cases of: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. The indications for use of the constrained liners compatible with this system are as follow: The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. ## Device Story Regenerex™ RingLoc® + Modular Acetabular Shell is a metallic, hemispherical, modular acetabular component for total hip replacement. Device features Regenerex™ (porous Ti-6Al-4V) coating on exterior fixation surface for bone ingrowth. System utilizes modular polyethylene liner and modular femoral head taper-fitted to femoral stem intra-operatively. Used by orthopedic surgeons in clinical/surgical settings. Provides stable acetabular interface for hip arthroplasty; benefits patients by restoring joint function and stability in cases of degenerative disease, fracture, or revision. ## Clinical Evidence No clinical data provided. Substantial equivalence supported by design verification and validation bench testing. ## Technological Characteristics Metallic, hemispherical, modular acetabular shell. Exterior surface coated with Regenerex™ (porous Ti-6Al-4V). Modular polyethylene liner and femoral head components. Uncemented or cemented application. ## 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. ## Predicate Devices - Porous Coated Acetabular Components ([K050124](/device/K050124.md)) ## 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}------------------------------------------------ K070369 BIOMET ## 510(k) Summary Preparation Date: March 7, 2007 Applicant/Sponsor: Biomet Manufacturing Corp. Contact Person: Robert Friddle, Requlatory Affairs Specialist Proprietary Name: Regenerex™ RingLoc® + Modular Acetabular Shell Common Name: Acetabular component for a total hip replacement ## Classification Code(s)/Name(s): Class II Product Classification Codes, Names and Regulation numbers: - 1. JDG, prosthesis, hip, femoral component, cemented, metal 21 CFR 888.3360 - 2. JDI, prosthesis, hip, semi-constrained, metal/polymer, cemented 21 CFR 888.3350 - 3. KWZ, prosthesis, hip, constrained, cemented or uncemented, metal/polymer 21 CFR 888.3310 - 4. LPH, prosthesis, hip, semi-constralned, metal/polymer, porous Uncemented 21 CFR 888.3358 - 5. LWJ, prosthesis, hip, semi-constrained, metal/polymer, Uncemented 21 CFR 888.3360 - 6. LZO, prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or nonporous, Uncemented 21 CFR 888.3353 - 7. MAY, prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or nonporous cemented, osteophilic finish 21 CFR 888.3353 - 8. MBL, prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous 21 CFR 888.3358 - 9. MEH, prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium-phosphate 21 CFR 888.3353 Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Porous Coated Acetabular Components, 510(k) K050124, deared October 4, 2005 Device Description: All devices are metallic, hemispherical, modular acetabular shell components. All shells have Regenerex™ (porous Ti-6Al-4V) applied to the exterior fixation surface. Each shell utilizes a modular polyethylene liner and a modular femoral head component that is a taper fit onto a femoral stem intra-operatively. Image /page/0/Figure/20 description: The image shows the mailing address, shipping address, office number, fax number, and email address. The mailing address is P.O. Box 587, Warsaw, IN 46581 0587. The shipping address is 56 E. Bell Drive, Warsaw, IN 46682. The office number is 574.267.66.39, the fax number is 574.267.8137, and the email address is biomet@biomet.com. 9 - Page 1 of 2 MAR 0 9 2007 {1}------------------------------------------------ K070369 Biomet Manufacturing Corp. Regenerex Modular Acetabular Shell Page 2 of 2 Intended Use: Cemented or non-cemented total hip replacement in cases of: - 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - 2. Rheumatoid arthritis - 3. Correction of functional deformity - 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. - 5. Revision procedures where other treatment or devices have falled. The indications for use of the constrained liners compatible with this system are as follow: The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, bone loss, foint or soft tissue laxity, neuromuscular disease, or intra-operative instablify and for whom all other options to constrained acetabular components have been considered. Summary of Technologies: The devices covered by this 510(k) are geometrically similar or identical to the predicate. Non-Clinical Testing: Device speditc risk analysis resulted in performance of design verification bench tests and validation activities. The results of design verification and validation activities do not raise new issues of safety and effectiveness. Clinical Testing: None provided. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines beneath them. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 0 9 2007 Biomet Manufacturing Corp. c/o Mr. Robert Friddle Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587 Re: K070369 Trade/Device Name: Regenerex™ RingLoc® + Modular Acetabular Shell Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, JDI, JDG, KWZ, LWJ, LZO, MAY, MBL, MEH Dated: January 29, 2007 Received: February 8, 2007 Dear Mr. Friddle: 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 {3}------------------------------------------------ Page 2 - Mr. Robert Friddle 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. 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark A. Millerson Mark N. Melkerson Director Division of General, Restorative Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use K070369 510(k) Number (if known): Device Name: Regenerex™ RingLoc® + Modular Acetabular Shell Indications For Use: Cemented or non-cemented total hip replacement in cases of: - 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - 2. Rheumatoid arthritis - 3. Correction of functional deformity - 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. - 5. Revision procedures where other treatment or devices have failed. The Indications for use of the constrained liners compatible with this system are as follow: The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered. Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use NO (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mark M. Millman (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number K070369 3 - Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K070369](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LPH/K070369) **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