OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)

{0} JAN 27 1997 Osteonics® Modular Acetabular Cup (MicroStructured® Version) 510(k) Summary # 510(k) Premarket Notification ## Summary of Safety and Effectiveness for the ## Osteonics® Modular Acetabular Cup ## (MicroStructured® Version) **K963946** ### Submission Information | Name and Address of the Sponsor of the 510(k) Submission: | Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677 | | --- | --- | | Contact Person: | Terry Sheridan Regulatory Affairs Specialist | | Date of Summary Preparation: | October 1, 1996 | ### Device Identification | Proprietary Name: | Osteonics® Modular Acetabular Cup | | --- | --- | | Common Name: | Artificial Acetabular Component | | Classification Name and Reference: | Hip Joint Metal/Polymer/Metal Semi-Constrained, Porous Coated, Uncemented Prosthesis 21 CFR §888.3358 | ### Predicate Device Identification The Osteonics® Modular Acetabular Cup components are substantially equivalent to the following competitive and/or Osteonics devices, which have previously been determined substantially equivalent by FDA: - Osteonics® Omnifit® PSL® MicroStructured® Shells: Osteonics Corporation. - Osteonics® Restoration GAP Acetabular Cups: Osteonics Corporation. - Osteonics® Omnifit® Cup Inserts: Osteonics Corporation. Page 1 {1} Osteonics® Modular Acetabular Cup (MicroStructured® Version) 510(k) Summary ## Device Description The Osteonics® Modular Acetabular Cup components are single-use devices. Each Osteonics® Modular Acetabular Cup consists of two pieces: an Osteonics® PSL® MicroStructured® ABC Shell, and a mating Osteonics® ABC Cementable Polyethylene Insert. The metal shell is intended for cemented or cementless fixation within the prepared acetabulum. The polyethylene insert is intended for cemented assembly to the metal shell. ## Intended Use: The Osteonics® Modular Acetabular Cup components are single-use devices. The polyethylene insert is intended for cemented assembly to the metal shell. The metal shell is intended for cemented or cementless fixation within the prepared acetabulum. The Osteonics® Modular Acetabular Cup is compatible with any appropriately selected Osteonics hip stem/femoral head combination. In addition, the Osteonics® ABC Cementable Polyethylene Insert - because its assembly method is independent of the inner geometry of the mating shell - is compatible with any commercially-available Osteonics metal acetabular shell component. ## Indications: The indications for the use of the Osteonics® Modular Acetabular Cup, in keeping with those of other legally marketed Osteonics acetabular components, are as follows: - Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. - Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. - Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. - Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. ## Statement of Technological Comparison: The substantial equivalence of the Osteonics® Modular Acetabular Cup System components to the predicate devices identified above - in terms of materials, intended uses, and design features - is based on the following. ## Materials: **Osteonics® PSL® MicroStructured® ABC Shells** The Osteonics® PSL® MicroStructured® ABC Shells, like the predicate Osteonics® Omnifit® PSL® MicroStructured® Shells are manufactured from ASTM F-67 Commercially Pure Titanium, and feature a beaded, porous coating of ASTM F-67 CP Titanium beads. Page 2 {2} Osteonics® Modular Acetabular Cup (MicroStructured® Version) 510(k) Summary # Osteonics® ABC Cementable Polyethylene Inserts The mating Osteonics® ABC Cementable Polyethylene Inserts, like the predicate Osteonics® Omnifit® Cup Inserts (Series II), are manufactured from UHMWPE. # Intended Use: ## Osteonics® PSL® MicroStructured® ABC Shells The subject Osteonics® PSL® MicroStructured® ABC Shells and the predicate Osteonics® Omnifit® PSL® MicroStructured® Shells share the same indications for use, and both shells are intended for cemented or cementless fixation within the prepared acetabulum. ## Osteonics® ABC Cementable Polyethylene Inserts The subject Osteonics® ABC Cementable Polyethylene Inserts and the predicate Osteonics® Omnifit® Cup Inserts share the same indications for use. The Osteonics® ABC Cementable Polyethylene Inserts are intended for cemented assembly to their mating shells. This assembly method is predicated by the commercially available Osteonics® Omnifit® Cup Inserts (Series II), which have been determined substantially equivalent for cemented assembly to the commercially available Osteonics® Restoration GAP Acetabular Shells. # Design: ## Osteonics® PSL® MicroStructured® ABC Shells The subject Osteonics® PSL® MicroStructured® ABC Shells differ most notably from the commercially available Osteonics® Omnifit® PSL® MicroStructured® Shells with regard to their interior geometries. The subject device has a tapered interior geometry, and is intended to receive a cementable polyethylene insert. Both the subject Osteonics® PSL® MicroStructured® ABC Shells and the predicate Osteonics® Omnifit® PSL® MicroStructured® Acetabular Shells are manufactured from the same materials, feature the same basic shape, and feature the same Osteonics® MicroStructured® coating. ## Osteonics® ABC Cementable Polyethylene Inserts The Osteonics® ABC Cementable Polyethylene Inserts have several features which make them relatively more amenable to the cemented assembly method than their predicate inserts. These features include: - Machined-in grooves: These grooves allow interdigitation with the bone cement. - Roughened outer/back surface: The back/outer surface of the insert has been roughened to provide a stronger insert/cement interface than would be characteristic of a smoother polyethylene surface. Neither the machined-in grooves, nor the roughened finish of the outer surface raise any new questions with regard to safety or effectiveness; both of these features are routinely employed in commercially available, one-piece, all-polyethylene acetabular cup designs. Page 3 {3} Osteonics® Modular Acetabular Cup (MicroStructured® Version) 510(k) Summary Both the subject Osteonics® ABC Cementable Polyethylene Inserts and the predicate Osteonics® Omnifit® Cup Inserts (Series II) maintain a bearing area polyethylene thickness which is ≥6mm. Both the subject and the predicate inserts come in a wide range of inner diameter and outer diameter sizes. Both the subject and the predicate inserts come in versions with a 0°, 10°, or 20° hooded face. ## Performance Data: Laboratory testing was undertaken to characterize the push-out strength of the Osteonics® ABC Cementable Polyethylene Inserts when assembled to their mating acetabular shells. The test results demonstrate that the shell/insert assembly method for the Osteonics® Modular Acetabular Cup components is comparable in terms of push-out strength to predicate shell/insert assembly methods and mechanisms. Page 4