HEDROCEL ACETABULAR RESTRICTOR

K962468 · Implex Corp. · JDI · Feb 3, 1997 · Orthopedic

Device Facts

• Record ID: K962468
• Device Name: HEDROCEL ACETABULAR RESTRICTOR
• Applicant: Implex Corp.
• Product Code: JDI · Orthopedic
• Decision Date: Feb 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hedrocel® Acetabular Restrictor is a device intended for restriction of effusion of bone cement, allograft bone, and/or autograft bone into the pelvis if defects in the acetabulum are encountered.

Device Story

Hedrocel® Acetabular Restrictor; tantalum-coated vitreous carbon lattice mesh; used to restrict effusion of bone cement, allograft, or autograft into pelvis during acetabular defect repair; available in three sizes; implanted by orthopedic surgeons during hip procedures; prevents migration of graft/cement materials into pelvic space.

Clinical Evidence

Bench testing only.

Technological Characteristics

Surgical mesh; tantalum deposited on reticulated vitreous carbon (RVC) skeleton; dodecahedron-shaped, fully interconnecting pores; ~80% bulk volume porosity; three sizes; open lattice design.

Indications for Use

Indicated for patients undergoing acetabular surgery where defects are encountered, requiring restriction of bone cement, allograft, or autograft material into the pelvis.

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

• Zimmer Cement Restrictor #4043-20
• Howmedica Charnley Cement Restrictor
• Motech Titanium Surgical Mesh

Submission Summary (Full Text)

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K962468

Implex Corp.
510(k) Number K962468
510(k) Deficiency Letter Dated September 6, 1996

FEB - 3 1997

# 510(k) SUMMARY - HEDROCEL® ACETABULAR RESTRICTOR

Submitter Name: Implex Corp.

Submitter Address: 80 Commerce Drive
Allendale, New Jersey 07401-1600

Contact Person: Robert Cohen, Vice President, Product Development

Phone Number: [phone]

Fax Number: [phone]

Date Prepared: November 21, 1996

Device Trade Name: Hedrocel® Acetabular Restrictor

Device Common Name: Prosthesis, Hip, Cement Restrictor

Classification Name: Surgical Mesh (per CFR § 878.3300)

Predicate Devices:
Zimmer Cement Restrictor #4043-20
Howmedica Charnley Cement Restrictor
Motech Titanium Surgical Mesh

Device Description: The Hedrocel® Acetabular Restrictor is manufactured as a surgical mesh fabricated from Hedrocel® porous metal. The tantalum lattice mesh device is available in three (3) sizes. The Hedrocel® material is a tantalum deposited upon vitreous carbon construct which possesses dodecahedron shaped, fully interconnecting pores resulting in a relatively high bulk volume porosity, approximately 80%. Cement restrictors are classified as Surgical Meshes.

Intended Use: The Hedrocel® Acetabular Restrictor is a device intended for restriction of effusion of bone cement, allograft bone, and/or autograft bone into the pelvis if defects in the acetabulum are encountered.

Device Technological Characteristics and Comparison to Predicate Devices:
The design features of the Hedrocel® Acetabular Restrictor are identical to the predicate devices. For example, these devices all use an open lattice design and are fabricated from metallic alloys. The specific alloys utilized varies among the devices. The Hedrocel® Acetabular Restrictor is manufactured using a process in which tantalum is deposited onto a reticulated vitreous carbon (RVC) skeleton.

Conclusion: The Hedrocel® Acetabular Restrictor is substantially equivalent to predicate devices in terms of intended use, safety, and effectiveness.

13604:9.0:84:11/21/96