← Product Code [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI) · K983136 # DEPUY LUSTER STEM (K983136) _DePuy Orthopaedics, Inc. · JDI · Nov 25, 1998 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K983136 ## Device Facts - **Applicant:** DePuy Orthopaedics, Inc. - **Product Code:** [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI.md) - **Decision Date:** Nov 25, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3350 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The DePuy Luster Stem is indicated for cemented use as the femoral component in total hip arthroplasty for replacing the hip joint of a patient whose hip joint has been damaged by degenerative joint disease, fracture, or the failure of a previous arthroplasty. ## Device Story DePuy Luster Stem is a polished, distally tapered femoral hip prosthesis; manufactured from forged cobalt chrome molybdenum alloy. Device features proximal anterior/posterior flange, medial 30° collar, and lateral proximal oval driver hole. Available in five sizes with standard or high offset options. Used in total hip arthroplasty; implanted by orthopedic surgeons in clinical settings. Device functions as femoral component; cemented into femoral canal; accepts modular metal or ceramic femoral heads via 12/14mm male taper. Compatible with PMMA centralizers and cement restrictors. Polished surface finish facilitates cement interface. Replaces damaged hip joints; restores joint function; alleviates pain associated with degenerative disease or fracture. ## Clinical Evidence No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to predicate devices. ## Technological Characteristics Material: Forged cobalt chrome molybdenum alloy. Design: Distally tapered femoral stem, proximal anterior/posterior flange, medial 30° collar, 12/14mm male taper. Surface: Polished. Connectivity: None. Energy: None. Sterilization: Not specified. Form factor: Five sizes with standard/high offset options. ## 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 - DePuy Cemented Hip Prosthesis (Endurance) ([K942370](/device/K942370.md)) - CPT Hip Prosthesis ([K960658](/device/K960658.md)) - Exeter Total Hip System ([K974054](/device/K974054.md), [K980843](/device/K980843.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}------------------------------------------------ # 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS | SPONSOR OF THIS 510(K): | DePuy, Inc.
P.O. Box 988
Warsaw, Indiana 46581-0988 | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(K) CONTACT: | Sally Foust
DePuy Orthopaedics, Inc.
Sr. Regulatory Submissions Associate
(219) 372-7455; FAX (219) 267-7098
E-mail: Sally_Foust@ccgate.depuy.com | | TRADE NAME: | DePuy Luster Stem | | COMMON NAME: | Hip Prosthesis | | CLASSIFICATION: | Class II per 888.3350, Hip joint metal/polymer semi-
constrained cemented prosthesis | | DEVICE CODE: | JDI | | EQUIVALENT DEVICES: | DePuy Cemented Hip Prosthesis (Endurance)(K942370)
CPT Hip Prosthesis (K960658)
Exeter Total Hip System (K974054, K980843) | #### DEVICE DESCRIPTION AND INTENDED USE: The DePuy Luster Stem is a polished, distally tapered femoral stem with a proximal anterior/posterior flange, a medial 30° collar, and an oval driver hole in the lateral proximal shoulder. The DePuy Luster Stem is available in five sizes (1, 2, 3, 4, and 5) each with two offset options, standard and high, and is manufactured from forged cobalt chrome molybdenum alloy. The DePuy Luster Stem is indicated for cemented use as the femoral component in total hip arthroplasty for replacing the hip joint of a patient whose hip joint has been damaged by degenerative joint disease, fracture, or the failure of a previous arthroplasty. #### BASIS OF SUBSTANTIAL EQUIVALENCE: The Luster Stem is identical in design, material and intended use to the FDA cleared Endurance (K942370) femoral stem. Both stems are distally tapered femoral stems with a proximal anterior/posterior flange, a medial 30° collar, and an oval driver hole in the lateral proximal shoulder. Both stems have a 12/14mm self-locking male taper at the neck to allow for the use of interchangeable modular metal or ceramic femoral heads. Both stems are available in five sizes (1, 2. 3. 4. and 5) each with a standard and high offset option. Both stems accept a PMMA centralizer at the distal tip and may be used with a cement restrictor. Both stems are manufactured from forged cobalt chrome molybdenum alloy and are intended for cemented use as the femoral component in total hip arthroplasty for replacing the hip joint of patients whose hip joint has been damaged by degenerative joint disease, fracture, or the failure of a previous arthroplasty. The only difference ## 000004 {1}------------------------------------------------ between the Luster stem and the FDA cleared Endurance stem is that the entire surface finish of the I uster stem is polished while the Endurance stem has a matte finish on the lateral and distal stem, and is grit blasted under the proximal flange. The Luster stem is similar in material, design, and intended use to the FDA cleared CPT Hip Prosthesis in that the both stems are manufactured from cobalt chrome, are polished, and are intended for cemented use with the use of femoral canal centering devices (i.e., centralizers). The Luster stem is similar in design and intended use to the FDA cleared Exeter Total Hip System in that hoth stems are polished and are intended for cemented use with the use of femoral canal centering devices. Based on similarities of design, materials and intended use, DePuy believes that the Luster Stem 1s substantially equivalent to the FDA cleared Endurance, CPT, and Exeter Hip Systems. | | LUSTER | ENURANCE
(K942370) | CPT
(K960658) | EXETER
(K974054,
K980843) | |----------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------| | Material | Cobalt-Chrome | Cobalt-Chrome | Cobalt-Chrome | 316L Stainless
Steel | | Use | Cemented | Cemented | Cemented | Cemented | | Design | Medial 30°
Collar,
Proximal
Flange,
Two Tapers,
Polished Finish | Medial 30°
Collar,
Proximal
Flange,
Two Tapers.
Matte Finish | Collarless,
Slim Profile,
Two Tapers,
Polished Finish | Collarless,
Slim Profile,
Two Tapers,
Polished Finish | | Modular
Heads | Yes | Yes | Yes | Yes | | EndCaps/
Centralizers/
Cement
Restrictors | Yes | Yes | Yes | Yes | The following table summarizes the similarities: {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. Nov 2 5 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Sally Foust Senior Requlatory Submissions Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Re : K983136 Trade Name: DePuy Luster Stem Requlatory Class: II Product Code: JDI September 4, 1998 Dated: Received: September 8, 1998 Dear Ms. Foust: 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 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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. Sally Foust 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 labelinq 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 requlation 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)_ k963136 Device Name: DePuy Luster Stem Indications for Use: The DePuy Luster Stem is indicated for cemented use as the femoral component in total hip arthroplasty for replacing the hip joint of a patient whose hip joint has been damaged by degenerative joint disease, fracture, or the failure of a previous arthroplasty. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Concurrence of CDRH, Office of Device Evaluation Prescription Use_ X (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Divis Sign-Off Division of General Restorative Devices 510(k) Number ### 000003 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K983136](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K983136) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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