OXYGENLESS PACKAGING CONVERSION OF LEGACY CENTERPULSE STANDARD POLYETHYLENE DEVICES

K061882 · Zimmer, Inc. · JWH · Aug 1, 2006 · Orthopedic

Device Facts

Record IDK061882
Device NameOXYGENLESS PACKAGING CONVERSION OF LEGACY CENTERPULSE STANDARD POLYETHYLENE DEVICES
ApplicantZimmer, Inc.
Product CodeJWH · Orthopedic
Decision DateAug 1, 2006
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 888.3560
Device ClassClass 2
AttributesTherapeutic

Intended Use

Indications for use of the proposed devices will not change from the indications for use as described in their respective predicate device 510(k) submissions.

Device Story

Device consists of legacy Centerpulse standard ultra-high molecular weight polyethylene (UHMWPE) orthopedic components (knee and hip systems) transitioned to Zimmer, Inc. nitrogen-flushed packaging. No changes to device design, materials, or clinical indications; modification limited to packaging configuration to standardize with Zimmer, Inc. protocols. Nitrogen-flushed packaging replaces previous oxygen-absorber packaging to maintain shelf-life integrity and prevent surface oxidation. Used by orthopedic surgeons in clinical/hospital settings for joint replacement procedures. Benefits include maintained material integrity and standardized supply chain logistics.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing comparing residual oxygen levels and surface oxidation indices between legacy Centerpulse packaging (with oxygen absorber) and Zimmer, Inc. nitrogen-flushed packaging after long-term shelf-life aging.

Technological Characteristics

Standard UHMWPE orthopedic components. Packaging: Nitrogen-flushed barrier packaging. No changes to device dimensions, materials, or mechanical properties.

Indications for Use

Indicated for patients requiring total or unicondylar knee arthroplasty or total/hemi-hip arthroplasty, consistent with the original indications for the legacy Centerpulse UHMWPE components.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Kou1882 (pg 1 of 3) # AUG 0 1 2005 # Summary of Safety and Effectiveness | Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 | |-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Mason W. Robbins<br>Regulatory Affairs Specialist<br>Telephone: (574) 371-8065<br>Fax: (574) 372-4605 | | Date: | June 30, 2006 | | Trade Names: | Apollo® Knee System<br>APR® Hip System<br>Bipolar Prosthesis<br>Epsilon™ Acetabular System<br>MOST® System<br>Natural-Knee® System<br>Natural-Knee® II System | | Common Names: | Total Knee Prosthesis, Articulating Surface<br>Unicondylar Knee Prosthesis, Articulating Surface<br>Total Hip Prosthesis, Bipolar Prosthesis<br>Total Hip Prosthesis, Acetabular Articulating<br>Surface | | Classification Names<br>and References: | Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained cemented<br>prosthesis, 21 CFR 888.3560<br>Hip joint metal/ceramic/polymer semi-constrained<br>cemented or nonporous uncemented prosthesis, 21<br>CFR 888.3353<br>Hip joint femoral (hemi-hip) metal/polymer<br>cemented or uncemented prosthesis, 21 CFR<br>888.3390<br>Hip joint metal/polymer/metal semi-constrained<br>porous-coated uncemented prosthesis, 21 CFR<br>888.3358<br>Hip joint metal/polymer semi-constrained cemented<br>prosthesis, 21 CFR 888.3350 | | | Knee joint femorotibial metal/polymer constrained<br>cemented prosthesis, 21 CFR 888.3510<br>Knee joint femorotibial metal/polymer semi-<br>constrained cemented prosthesis, 21 CFR 888.3530<br>Knee joint femorotibial (uni-compartmental)<br>metal/polymer porous-coated uncemented<br>prosthesis, 21 CFR 888.3535 | | Predicate Devices: | All standard ultra high molecular weight<br>polyethylene (UHMWPE) components of the<br>following legacy Centerpulse trade names:<br>Apollo® Knee System<br>APR® Hip System<br>Bipolar Prosthesis<br>Epsilon™ Acetabular System<br>MOST® System<br>Natural-Knee® System<br>Natural-Knee® II System | | Device Descriptions: | All standard UHMWPE components of the<br>following legacy Centerpulse trade names:<br>Apollo® Knee System<br>APR® Hip System<br>Bipolar Prosthesis<br>Epsilon™ Acetabular System<br>MOST® System<br>Natural-Knee® System<br>Natural-Knee® II System | | Intended Uses: | Indications for use of the proposed devices will not<br>change from the indications for use as described in<br>their respective predicate device 510(k)<br>submissions. | | Comparison to Predicate Devices: | The proposed devices are identical to the predicate<br>devices. The packaging for the legacy Centerpulse<br>standard UHMWPE devices will be changed from<br>the current packaging to the packaging used for<br>legacy Zimmer, Inc. UHMWPE device in order to<br>standardize packaging within Zimmer, Inc. | | Performance Data (Non-clinical<br>and/or Clinical): | Non-clinical Performance and Conclusions:<br>Package configurations for legacy Zimmer Inc. and<br>legacy Centerpulse were compared for levels of | {1}------------------------------------------------ K Q6142 (pg 2 of 3) {2}------------------------------------------------ Koblitz (pg. 53) residual oxygen and surface oxidation index in standard polyethylene devices after long-term shelflife aging. The legacy Zimmer Inc. nitrogenflushed package outperformed the legacy Centerpulse package containing an oxygen absorber. Surface oxidation was not detected on any of the samples, regardless of package configuration. The legacy Zimmer Inc. nitrogenflushed package for standard polyethylene devices is sufficient for use for packaging of legacy Centerpulse standard polyethylene inserts. Zimmer Inc. does not believe clinical data are needed in support of this submission. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The bird is positioned within a circular border. The text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES" is arranged around the upper portion of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 0 1 2006 Zimmer, Inc % Mason W. Robbins, MS, RPCV, CCRP Regulatory Affairs Specialist P.O. Box 708 Warsaw, Indiana 46581 Re: K061882 Trade/Device Name: Oxygenless Packaging Conversion of Legacy Centerpulse Standard Polyethylene Devices Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MEH, LPH, JDI, KWY, KRO, HRY, NJD, LZO Dated: June 30, 2006 Received: July 3, 2006 Dear Mr. Robbins: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality {4}------------------------------------------------ Page 2 - Mason W. Robbins. MS. RPCV. CCRP systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrt/industry/support/index.html. Sincerely yours, Hubert Lemercier \$\int\$ Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K061882 ## Indications for Use ### 510(k) Number (if known): Device Name: Oxygenless Packaging Conversion of Legacy Centerpulse Standard Polyethylene Devices Apollo® Knee System Trade Names: APR& Anatomical Hip System Bipolar Prosthesis Epsilon™ Acetabular System MOST® System Natural-Knee® System Natural-Knee® II System ### Indications for Use: Indications for use of the proposed devices will not change from the indications for use as described in their respective predicate device 510(k)s; only a change in packaging is being proposed. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of D uation (ODE) > (Division Division of General, Restorative, and Neurological Devices 510(k) Number k061882
Innolitics
510(k) Summary
Decision Summary
Classification Order
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