← Product Code [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI) · K990032 # MODULAR PROTUSIO CUP (K990032) _Biomet, Inc. · JDI · Feb 18, 1999 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K990032 ## Device Facts - **Applicant:** Biomet, Inc. - **Product Code:** [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI.md) - **Decision Date:** Feb 18, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3350 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The indications for the Modular Protrusio Cup are as follows: - Noninflammatory degenerative joint disease including osteoarthritis and 1) avascular necrosis. - 2) Rheumatoid arthritis - Correction of functional deformity 3) - Treatment of nonunion, femoral neck fractures, and throchanteric fractures of 4) the proximal femur with head involvement, unmanageable using other techniques - Revision of failed joint construction or treatment ર) ## Device Story Modular Protrusio Cup is a hemispherical metallic acetabular reinforcement device; features hook, flange, or blade extensions for anatomical fit. Fabricated from CP titanium (flange/hook) and titanium alloy (cup/blade). Surgeon shapes malleable components intraoperatively; grit-blasted finish on hook/blade and plasma spray porous coating on cup enhance bone fixation. Secured via 6.5-mm low-profile screws. Used in orthopedic surgery to reinforce acetabular socket, facilitate bone grafting, and resist acetabular migration in cases of severe deficiency. Compatible with polyethylene ring-loc liners. Provides structural support to pelvic bone grafts, protecting against stress overload and collapse. ## Clinical Evidence No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices. ## Technological Characteristics Hemispherical acetabular cup with modular hook, flange, and blade attachments. Materials: Commercially pure (CP) titanium and titanium alloy. Surface treatments: Grit-blasted finish and plasma spray porous coating. Fixation: 6.5-mm low-profile screws. Modular design allows intraoperative shaping of flanges and hooks. Compatible with polyethylene ring-loc liners. ## 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 - Biomet's Modular Acetabular Reconstructive System (M.A.R.S) ([K911718](/device/K911718.md)) - Biomet's Healy Revision Component System ([K921139](/device/K921139.md)) - Biomet's Recovery protrusio Cage ([K971890](/device/K971890.md)) - Osteonics' Restoration GAP Acetabular Cup ([K943549](/device/K943549.md)) - Intermedics' Orthopaedics' Burch/Schneider Reinforcement Cage ([K960678](/device/K960678.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}------------------------------------------------ ## 9900 32 SUMMARY OF SAFETY AND EFFECTIVENESS SPONSOR: Biomet. Inc. P. O. Box 587 Airport Industrial Park Warsaw, Indiana 46581-0587 Dalene Hufziger Binkley CONTACT PERSON: PROPRIETARY NAME: Modular Protrusio Cup DEVICE NAME: Hip joint metal/polymer semi-constrained cemented prosthesis 888.3350. INTENDED USE: The indications for the Modular Protrusio Cup are as follows: - Noninflammatory degenerative joint disease including osteoarthritis and 1) avascular necrosis. - 2) Rheumatoid arthritis - Correction of functional deformity 3) - Treatment of nonunion, femoral neck fractures, and throchanteric fractures of 4) the proximal femur with head involvement, unmanageable using other techniques - Revision of failed joint construction or treatment ર) DEVICE DESCRIPTION: The Modular Protrusio Cup is a hemispherial metallic cup with a hook, flange, or blade extending from it. The ilium flange and hook are fabricated from commercially pure (CP) titanium. The cup and blade are made from titanium alloy. The malleable commercially pure (CP) titanium flange and hook can be shaped by the surgeon intraoperatively to fit the shape of the patient's anatomy. The surface of the hook and blade has a grit blasted (roughened) finish for potential enhanced fixation to the bone. The cup will have plasma spray porous coating to enhance potential fixation to any host bone available. The purpose of the cup is to provide reinforcement for the acetabular socket and facilitate bone grafting in cases of severely deficient acetabulum. The pelvic bone grafts are protected form stress overload and potential collapses with the cup. This device can potentially resist acetabular migration by serving as a connection between host bone and to host bone. There are several different options with the use of a hook and flanges. The flanges come in three different sizes, the blade in two and the hook in one. The use of 6.5-mm low profile screws is used to secure the flanges, hooks and cup in place. Any polyethylene ring-loc liner may be used with this system. The liner may be placed anteverted to correct anatomic position within the cage if need be. {1}------------------------------------------------ POTENTIAL RISKS: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to: Reaction to bone cement Fracture of the component Cardiovascular disorders Implant loosening/migration Soft tissue imbalance Deformity of the joint Dislocation Metal sensitivity Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Delayed wound healing Fracture of the cement SUBSTANTIAL EQUIVALENCE: The Modular Protrusio Recovery Cup is substantially equivalent to other acetabular cage devices on the market in overall design and intended function. The following devices are predicates to the Modular Protrusio Cup: Biomet's Modular Acetabular Reconstructive System (M.A.R.S) (K911718), Biomet's Healy Revision Component System (K921139), Biomet's Recovery protrusio Cage (K971890), Osteonics' Restoration GAP Acetabular Cup (K943549), and Intermedics' Orthopaedics' Burch/Schneider Reinforcement Cage (K960678). {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of three wavy lines that resemble a person. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 1 8 1999 Ms. Dalene Hufziger Binkley Regulatory Specialist Biomet, Inc. Airport Industrial Park P.O. Box 587 46581-0587 Warsaw, Indiana K990032 Re: Modular Protrusio Cup Requlatory Class: II JDI Product Code: December 30, 1998 Dated: Received: January 6, 1999 Dear Ms. Binkley: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ ## Page 2 - Ms. Dalene Hufziger Binkley This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510 (k) NUMBER (IF KNOWN): L S 9 9 0 0 3 2 ## DEVICE NAME: Modular Protrusio Cup ## INDICATIONS FOR USE: The indications for the Modular Protrusio Cup are as follows: - 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. - 2) Rheumatoid arthritis - 3) Correction of functional deformity - 3) Correction of nonunion, femoral neck fractures, and throchanteric fractures of Treatment of nomanon, remoring involvement, unmanageable using other techniques - 5) Revision of failed joint construction or treatment (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) × Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use (Optional Format 1-2-96) ral Restorative Devi --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K990032](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K990032) **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