Who is the manufacturer of IM C-MENT ACETABULAR CAP?

Implant Ideas, LLC filed the 510(k) submission for IM C-MENT ACETABULAR CAP (K955137).

What is the FDA product code for IM C-MENT ACETABULAR CAP?

JDI. It is classified under 21 CFR 888.3350 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for IM C-MENT ACETABULAR CAP?

510(k) clearance (submission type: Traditional).

What are the predicate devices for IM C-MENT ACETABULAR CAP?

M.E. Muller Type Acetabular Cups (DePuy); Charnley Type Acetabular Cup (DePuy); New England Baptist Hip Cups (DePuy).

Who can help prepare an FDA 510(k) submission like IM C-MENT ACETABULAR CAP?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

IM C-MENT ACETABULAR CAP

K955137 · Implant Ideas, LLC · JDI · Oct 10, 1996 · Orthopedic

Device Facts

Record ID	K955137
Device Name	IM C-MENT ACETABULAR CAP
Applicant	Implant Ideas, LLC
Product Code	JDI · Orthopedic
Decision Date	Oct 10, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3350
Device Class	Class 2
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.

Indications for Use

Indicated for patients requiring acetabular socket resurfacing due to femoral head/neck fractures, nonunion of fractures, aseptic necrosis, osteoarthritis, rheumatoid arthritis, or revision of failed prostheses.

Regulatory Classification

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)

Related Devices

K964003 — METAGEN ALL POLY ACETABULAR CUP SYSTEM · Metagen, LLC · Mar 21, 1997
K980774 — OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS · Osteonics Corp. · Apr 29, 1998
K963671 — OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP · Osteonics Corp. · Feb 3, 1997
K051407 — LEGEND ALL-POLY CUP · Ortho Development Corp. · Sep 8, 2005
K983837 — HEDROCEL ACETABULAR CAGE SYSTEM · Implex Corp. · Jul 1, 1999

Submission Summary (Full Text)

{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.