Who is the manufacturer of ATLAS III ACETABULAR CUP?

Fournitures Hospitalieres submitted the Traditional clearance for ATLAS III ACETABULAR CUP (K961388).

What is the FDA product code for ATLAS III ACETABULAR CUP?

MEH. It is classified under 21 CFR 888.3353 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for ATLAS III ACETABULAR CUP?

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

What are the predicate devices for ATLAS III ACETABULAR CUP?

Hydroxylapatite McCutchen Acetabular Cup (K912452); Omnifit-HA Acetabular Cup (K911728); Secure-Fit HA PSL Extra Acetabular Component System (K954023).

ATLAS III ACETABULAR CUP

K961388 · Fournitures Hospitalieres · MEH · Apr 3, 1997 · Orthopedic

Device Facts

Record ID	K961388
Device Name	ATLAS III ACETABULAR CUP
Applicant	Fournitures Hospitalieres
Product Code	MEH · Orthopedic
Decision Date	Apr 3, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3353
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The ATLAS® III Acetabular Cup is intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, and revision of previously failed hip arthroplasties. The device is designed for cementless application.

Device Story

ATLAS® III Acetabular Cup; cementless hip prosthesis. Features 8 axial screw holes, 4 locking pegs for impaction anchoring, 1 dome hole for impaction verification, 2mm slot for stability. Available in 12 outer diameters (46-68mm); polyethylene inserts in 4 inner diameters (22.2-32mm). Used in orthopedic surgery; implanted by surgeon. Optional screw fixation determined intraoperatively. Polyethylene insert placed into shell post-impaction. Provides stable acetabular component for hip arthroplasty; restores joint function.

Clinical Evidence

Bench testing only. Data provided to characterize materials, hydroxylapatite coating, and performance characteristics under defined laboratory conditions.

Technological Characteristics

Cementless acetabular cup; hydroxylapatite coating. Features 8 axial screw holes, 4 locking pegs, 1 dome hole, 2mm stability slot. Polyethylene inserts. Sizes: 46-68mm OD; 22.2-32mm ID. Mechanical fixation via impaction and optional screws.

Indications for Use

Indicated for patients with degenerative or inflammatory hip arthritis, trauma, or requiring revision of failed hip arthroplasties.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

Hydroxylapatite McCutchen Acetabular Cup (K912452)
Omnifit-HA Acetabular Cup (K911728)
Secure-Fit HA PSL Extra Acetabular Component System (K954023)

Related Devices

K970957 — OSTEONICS RESTORATION ACETABULAR RING · Osteonics Corp. · Jun 3, 1997
K141043 — CS2 MULTI-HOLE ACETABULAR SHELL · Consensus Orthopedics, Inc. · May 19, 2014
K960094 — REFLECTION DUAL DIMENSION SHELL · Smith & Nephew Richards, Inc. · Mar 27, 1996
K112779 — APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM) · Omnlife Science · Dec 2, 2011
K961186 — DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM · Depuy, Inc. · Sep 17, 1996

Submission Summary (Full Text)

{0} K961388 APR -3 1997 # 510(k) SUMMARY - ATLAS® III Acetabular Cup | Submitter Name: | Fournitures Hospitalieres Office Medico Chirurgical International | | --- | --- | | Submitter Address: | 6 rue Nobel, Z.I de Kernevez Quimper, France 29000 | | Contact Person: | C. Rafaitin | | Phone Number: | (+33) 98.55.68.95 | | Fax Number: | (+33) 98.53.42.13 | | Date Prepared: | April 9, 1996 | | Device Trade Name: | ATLAS® III Acetabular Cup | | Device Common Name: | Acetabular Cup | | Classification Name: | Prosthesis, Hip, Acetabular Component, Ultra High Molecular Weight Polyethylene | | Predicate Devices: | Hydroxylapatite McCutchen Acetabular Cup Dow Corning Wright (K912452) | | | Omnifit-HA Acetabular Cup Osteonics Corp. (K911728) | | | Secure-Fit HA PSL Extra Acetabular Component System Osteonics Corp. (K954023) | | Device Description: | The ATLAS® III Acetabular Cup is available in twelve (12) outer diameter (O.D.) sizes from 46 mm to 68 mm in two (2) mm increments. The polyethylene insert is available in four (4) possible inner diameter (I.D.) size options, 22.2 mm, 26 mm, 28 mm and 32 mm. The ATLAS® III Acetabular Cup instrumentation system is utilized for proper impaction of the device. | | Intended Use: | The ATLAS® III Acetabular Cup is intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, and revision of previously failed hip arthroplasties. The device is designed for cementless application. | Page 1 of 2 51 {1} Page 2 of 2 52 ## Device Technological Characteristics and Comparison to Predicate Devices: The ATLAS® III Acetabular Cup design includes eight (8) axial screw holes, four (4) locking pegs for anchoring the device during impaction, one (1) dome hole for verifying impaction, and a two (2) millimeter slot which closes up after impaction to assist implant stability. The use of screws for implant stability is optional and determined by the surgeon at the time of impaction. The polyethylene insert is placed into the acetabular shell by the surgeon once the shell is successfully impacted. Identified predicate devices have the same intended use and may incorporate some or all of the above described design features either alone or in combination. ## Performance Data: Testing conducted to characterize the materials, the hydroxylapatite coating, and the performance characteristics of the device under defined laboratory conditions was provided to support a finding of substantial equivalence. ## Conclusion: The ATLAS® III Acetabular Cup is substantially equivalent to predicate devices in terms of intended use, safety and effectiveness.