OSTEONICS N2/VAC PACKAGING PROCESS

K955944 · Osteonics Corp. · KWS · Apr 9, 1996 · Orthopedic

Device Facts

• Record ID: K955944
• Device Name: OSTEONICS N2/VAC PACKAGING PROCESS
• Applicant: Osteonics Corp.
• Product Code: KWS · Orthopedic
• Decision Date: Apr 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2

Intended Use

The packaging change which is the subject of this submission does not affect the intended uses of any of the commercially available UHMWPE components subject to the packaging change. The components which contain UHMWPE as a bearing will be packaged in an inert environment. The packaging method will reduce the oxygen content within the package, thereby retarding oxidation.

Device Story

Device is a packaging process for orthopedic implants containing UHMWPE bearings; utilizes nitrogen flush and vacuum sealing to create inert environment; reduces oxygen content to retard oxidation of UHMWPE material; replaces standard blister/lid materials with gas-permeable barriers; adds secondary pouch for increased gas transmission resistance; maintains sterility assurance level (SAL) of 10^-6; does not alter device design or clinical function; intended to preserve material integrity during storage.

Clinical Evidence

No clinical data; bench testing only. Packaging integrity and seal requirements verified to meet standards; sterility assurance level (SAL) of 10^-6 maintained.

Technological Characteristics

Packaging process using nitrogen flush and vacuum sealing. Materials: gas-permeable blister and lid stock replaced with low-permeability alternatives; secondary pouch added. Sterilization: radiation dose unchanged. No software or electronic components.

Indications for Use

Indicated for orthopedic implants containing UHMWPE bearing components previously cleared for clinical use.

Regulatory Classification

Identification

A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Special Controls

*Classification.* Class II. The special controls for this device are:(1) FDA's: (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” (iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,” (iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” (2) International Organization for Standardization's (ISO): (i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,” (ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,” (iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,” (iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,” (v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,” (vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and (vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (3) American Society for Testing and Materials': (i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,” (ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,” (iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,” (iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,” (vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Predicate Devices

• Howmedica Acetabular Components Packaging and Manufacturing Methods Change (K934060)
• Howmedica Knee Components Packaging and Manufacturing Methods Change (K936292)
• DePuy Vacuum Nitrogen (N2) Flush - Barrier Packaging (K940743)

Submission Summary (Full Text)

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K955944
APR - 9 1996

510(k) Premarket Notification
Summary of Safety and Effectiveness
for Change in Packaging for Osteonics’ UHMWPE Components

## 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 Jarosz
Regulatory Affairs Specialist |
| Date of Summary Preparation: | February 26, 1996 |

## Device Identification

| Proprietary Name: | Osteonics® N₂/Vac Packaging Process |
| --- | --- |
| Common Name: | Nitrogen flush/vacuum sealing packaging process |
| Classification Name and Reference: | Not Applicable |

## Predicate Device Identification

Devices packaged under the Osteonics® N₂/Vac Packaging Process are substantially equivalent to devices packaged under standard, room air conditions, as well as to devices packaged under the various, other packaging methods recently put forth by other orthopedic implant manufacturers. The following predicate 510(k)s are identified for comparison:

- K934060: Howmedica Acetabular Components Packaging and Manufacturing Methods Change
- K936292: Howmedica Knee Components Packaging and Manufacturing Methods Change
- K940743: DePuy Vacuum Nitrogen (N₂) Flush - Barrier Packaging

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Change in Packaging for Osteonics' UHMWPE Components
510(k) Summary

# Device Description

The devices which are subject to the proposed packaging change are Osteonics implants which contain UHMWPE as a bearing. These devices all have their own, previously established 510(k) clearances. This 510(k) does not address any changes to any component or its device description; it addresses only a change to the way that the devices will be packaged.

# Intended Use:

The packaging change which is the subject of this submission does not affect the intended uses of any of the commercially available UHMWPE components subject to the packaging change.

The components which contain UHMWPE as a bearing will be packaged in an inert environment. The packaging method will reduce the oxygen content within the package, thereby retarding oxidation.

# Statement of Technological Comparison:

As before, Osteonics' UHMWPE devices will continue to be packaged according to the previously featured "double blister" style method. However, in order to create an inert environment, the component packages will be flushed with Nitrogen and then vacuum sealed. This "N₂/Vac" feature requires the following changes to the package itself:

Changes to Actual Package:

1) The current blister material is replaced with a less gas-permeable material.
2) The current lid stock is replaced with a less gas-permeable lid stock.
3) The inner/outer blister assembly will be placed within a pouch, adding another gas transmission barrier to the final package.

The proposed change in Osteonics' packaging does not affect the device sterility. The sealed inner and outer packaging blisters meet the same package and seal requirements as the traditional Osteonics' packaging. The radiation dose required for sterility is not affected by the new packaging materials, and the sterility assurance level (SAL) of 10⁻⁶ remains unchanged.

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