← Product Code [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI) · K991227 # 8MM FORGED CEMENTED STEM (K991227) _Encore Orthopedics, Inc. · JDI · Jun 1, 1999 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K991227 ## Device Facts - **Applicant:** Encore Orthopedics, Inc. - **Product Code:** [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI.md) - **Decision Date:** Jun 1, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3350 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Foundation 8mm Cemented Hip Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty. The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments where devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. It is intended to be used with cement with acetabular components or with unipolar heads. ## Device Story Foundation 8mm Forged Cemented Stem is a femoral hip prosthesis; fabricated from forged CoCrMo alloy. Proximal body features trapezoidal geometry, anterior/posterior ribs, and PMMA buttons for centering in femoral canal with 1.5mm cement mantle. Distal portion is conical with flanged PMMA canal centralizer. Includes calcar collar and Morse taper for modular head attachment; 135° neck/stem angle. Used by orthopedic surgeons in clinical settings for total or hemi-hip arthroplasty. Device provides structural support for hip joint; restores function in patients with degenerative disease or fractures. Implanted via surgical procedure; requires bone cement. ## Clinical Evidence No clinical data. Evidence consists of bench testing, specifically finite element analysis demonstrating survival of 450 lbs for 5 million cycles, and laboratory testing of the Morse type taper. ## Technological Characteristics Material: Forged CoCrMo alloy. Geometry: Proximal trapezoidal body with ribs; distal conical stem. Features: PMMA canal centralizer, PMMA proximal spacers, Morse taper, calcar collar. Surface: Grit blasted proximal body (4-6 u). Energy: None (passive implant). Connectivity: None. Sterilization: Not specified. ## 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 - 9mm Forged Cemented Stem ([K961809](/device/K961809.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}------------------------------------------------ 6/1/99 # 510(k) Summary f Safety and Effectiven - (1) Submitter's name: Submitter's address: Submitter's telephone number: Contact person: Date summary prepared: - (2) Trade or proprietary device name: Common or usual name: Classification name: Encore Orthopedics, Inc. 9800 Metric Blvd., Austin, TX 78758 (512) 834-6237 Debbie De Los Santos April 7, 1999 8mm Forged Cemented Stem Cemented Hip Stem Hip joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3350 and Hip joint Femoral (hemi-hip) metallic cemented or uncemented prosthesis per 21 CFR 888.3360 - Legally marketed predicate device: 9mm Forged Cemented Stem (K961809) (3) - (4) Subject device description: The proximal body of the Foundation™ Non-Porous Stem is trapezoidal in cross-sectional geometry and tapers proximal to distal and lateral to medial. The proximal body has one rib on the anterior and posterior surfaces that run the length of the proximal body. Polymethylmethacrylate "buttons" are placed on the anterior, lateral and medial surfaces of the proximal body to assure that the implant is centered in the metaphseal region of the femur with a 1.5 mm cement mantle. The proximal body of the femoral stem is grit blasted to a surface of 4-6 u. This device is fabricated from forged CoCrMo alloy. The distal portion of the stem is conical in shape. It necks down at the distal end to receive a flanged PMMA canal centralizer. This centralizer assures that the distal stem is centered in the femoral canal and helps to maintain a even cement mantle around the distal stem. The Foundation 8mm Forged Cemented Stem has a calcar collar and has a Morse type taper to receive modular heads. The neck/stem angle is 135°. #### (5) Subject device intended use: The Foundation 8mm Forged Cemented Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty. The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments where devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. It is intended to be used with cement with acetabular components or with unipolar heads. #### (6) Basis for substantial equivalence: Features comparable to predicate devices include the Foundation® 9mm Forged Cemented Stems approved for commercial distribution in K961809, CoCrMo substrate, distal femoral canal centralizer, proximal cement spacers, calcar collar, proximal ribs on body, roughened proximal body, modular heads and unipolar heads. #### (7) Test Results This stem was analyzed using finite element analysis and is shown to survive 450 pounds for 5M cycles. Laboratory testing of the Morse type taper was conducted. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus-like symbol with three parallel lines that curve and resemble a stylized human form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 1 1999 JUN Ms. Debbie De Los Santos Regulatory/Clinical Specialist Encore Orthopedics 9800 Metric Boulevard Austin, Texas 78758 K991227 Re: 8mm Forged Cemented Stem Trade Name: Regulatory Class: II Product Code: JDI Dated: April 7, 1999 Received: April 12, 1999 ### Dear Ms. De Los Santos: 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. 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. {2}------------------------------------------------ Page 2 - Ms. Debbie De Los Santos This letter will allow you to begin marketing your device as rnscribed in your 510(k) premarket notification. The FDA assoring 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 {3}------------------------------------------------ K991227 510(k) Number (if known): __ Device Name: Indications For Use: ## Foundation® 8mm Cemented Hip Stem Indications For Use The indications for use of the Foundation 8mm cemented total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X OROver-The-Counter Use_ (per 21 CFR 801.109) (Optional Format 1-2-96)_ teolilo (Division Orvision 5 i Ok) Num --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K991227](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K991227) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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