← Product Code [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI) · K955137 # IM C-MENT ACETABULAR CAP (K955137) _Implant Ideas, LLC · JDI · Oct 10, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K955137 ## Device Facts - **Applicant:** Implant Ideas, LLC - **Product Code:** [JDI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI.md) - **Decision Date:** Oct 10, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3350 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The IM C-Ment Acetabular Cup will be used in indications which are the same as that for other acetabular components of cemented total hip replacement systems. Specifically, the IM C-Ment Acetabular Cup is intended to resurface the acetabular socket in cases of femoral head and neck fractures, nonunion of femoral head and neck fractures, femoral head aseptic necrosis, osteoarthritis, rheumatoid arthritis and revision of failed prostheses. The IM C-Ment Acetabular Cup is intended to be used in cemented applications only. ## Device Story Acetabular component for cemented total hip replacement; hemispherical all-polyethylene design. Features three concentric outer grooves and three circular indentations for cement fixation. Used by orthopedic surgeons in clinical settings to reconstruct hip joint articulation. Implanted in conjunction with femoral stem and head to restore joint spacing. Benefits patients by providing stable articulation in cases of degenerative joint disease or fracture. ## Clinical Evidence Bench testing only; no clinical data provided. Equivalence established through design comparison and material history. ## Technological Characteristics Material: UHMWPE. Geometry: Hemispherical, 28mm inner diameter, 40-60mm outer diameter. Features: Three concentric outer grooves, three circular indentations, x-ray markers. Application: Cemented fixation only. ## 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 - M.E. Muller Type Acetabular Cups (DePuy) - Charnley Type Acetabular Cup (DePuy) - New England Baptist Hip Cups (DePuy) ## 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} IM C-Ment Cup 510(k) Page 18 OCT 10 1996 K955137 510(k) Summary of Safety and Effectiveness Submitter: Implant Ideas, LLC 4036 Hagadorn Rd. Okemos, MI 48864 Phone: 517/333-1490 Fax: 517/333-1491 Contact: Brenda Sparks Date of Summary: 11/3/95 Product: Classification Name: Acetabular Component of Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis (21 CFR 888.3350) Generic Name: Acetabular Component of a Cemented Total Hip Replacement Trade/Proprietary Name: IM C-Ment Acetabular Cup Substantially Equivalent Products: M.E. Muller Type Acetabular Cups from DePuy Charnley Type Acetabular Cup from DePuy New England Baptist Hip Cups from DePuy Description: The IM C-Ment Acetabular Cup is an all-polyethylene, hemispherical acetabular component with three (3) concentric grooves on the outer diameter and 3 circular indentations equally-spaced around the circumference near the middle of the cup. It is provided in eleven (11) sizes for the 28mm inner diameter, ranging from outer diameters of 40mm to 60mm. Intended Use: The IM C-Ment Acetabular Cup will be used in indications which are the same as that for other acetabular components of cemented total hip replacement systems. Specifically, the IM C-Ment Acetabular Cup is intended to resurface the acetabular socket in cases of femoral head and neck fractures, nonunion of femoral head and neck fractures, femoral head aseptic necrosis, osteoarthritis, rheumatoid arthritis and revision of failed prostheses. The IM C-Ment Acetabular Cup is intended to be used in cemented applications only. - Comparison to Substantially Equivalent Products: All of the named acetabular cups use UHMWPE and Stainless Steel materials. These materials have a history of demonstrated success as implant materials for acetabular cups. The IM C-Ment Acetabular Cup is available in an inner diameter of 28mm. The other three cups have inner diameters of 22mm and 32mm. The IM C-Ment Acetabular Cup is available in outer diameters between 40 and 60mm. This is within the range of outer diameter sizes represented by the other three cups, i.e., 36 to 65mm. {1} IM C-Ment Cup 510(k) Page 19 All of the named acetabular cups are used to reconstruct the hip joint in combination with a femoral stem and head to provide appropriate joint spacing and femoral/acetabular articulation. In addition, all of the products are intended to be used in cemented applications. All of the named acetabular cups are hemispherical, with a concentric I.D., concentric cement grooves, circular x-ray wires. The only exceptions to this are: 1. The New England Baptist Hip Cup has an eccentric I.D. and uses two circular x-ray wires rather than one. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K955137](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDI/K955137) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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