(29 days)
Not Found
No
The submission explicitly states that only a change in packaging is being proposed and the device description focuses on standard UHMWPE components. There is no mention of AI or ML in the document.
Yes
The device explicitly states its intended use is for components of knee and hip systems like the Apollo® Knee System and APR® Hip System, which are used to treat or replace anatomical structures and thus have a therapeutic effect.
No
The document describes changes to medical device packaging (implants like knee and hip systems), not a diagnostic device. The performance studies focus on package integrity and material oxidation, not diagnosis.
No
The device description clearly states it is comprised of "standard UHMWPE components" which are physical, hardware-based implants for knee and hip systems. The submission is focused on a change in packaging for these physical components, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the devices are components of knee and hip systems (implants). IVDs are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The devices are described as standard UHMWPE components for surgical implants. This is consistent with medical devices used in the body, not for testing samples from the body.
- Anatomical Site: The anatomical sites are the knee and hip joints, which are where these implants are placed.
- Performance Studies: The performance studies focus on packaging and material properties (residual oxygen, surface oxidation index) of the implant components, not on the accuracy or performance of a diagnostic test.
The information provided strongly indicates that these are implantable medical devices, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
JWH, MEH, LPH, JDI, KWY, KRO, HRY, NJD, LZO
Device Description
All standard UHMWPE components of the following legacy Centerpulse trade names: Apollo® Knee System APR® Hip System Bipolar Prosthesis Epsilon™ Acetabular System MOST® System Natural-Knee® System Natural-Knee® II System
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint, Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical Performance and Conclusions: Package configurations for legacy Zimmer Inc. and legacy Centerpulse were compared for levels of residual oxygen and surface oxidation index in standard polyethylene devices after long-term shelf-life aging. The legacy Zimmer Inc. nitrogen-flushed 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. nitrogen-flushed package for standard polyethylene devices is sufficient for use for packaging of legacy Centerpulse standard polyethylene inserts.
Key Metrics
Not Found
Predicate Device(s)
All standard ultra high molecular weight polyethylene (UHMWPE) components of the following legacy Centerpulse trade names: Apollo® Knee System APR® Hip System Bipolar Prosthesis Epsilon™ Acetabular System MOST® System Natural-Knee® System Natural-Knee® II System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
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).(b)
Classification. Class II.
0
Kou1882 (pg 1 of 3)
AUG 0 1 2005
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mason W. Robbins
Regulatory Affairs Specialist
Telephone: (574) 371-8065
Fax: (574) 372-4605 |
| Date: | June 30, 2006 |
| Trade Names: | Apollo® Knee System
APR® Hip System
Bipolar Prosthesis
Epsilon™ Acetabular System
MOST® System
Natural-Knee® System
Natural-Knee® II System |
| Common Names: | Total Knee Prosthesis, Articulating Surface
Unicondylar Knee Prosthesis, Articulating Surface
Total Hip Prosthesis, Bipolar Prosthesis
Total Hip Prosthesis, Acetabular Articulating
Surface |
| Classification Names
and References: | Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented
prosthesis, 21 CFR 888.3560
Hip joint metal/ceramic/polymer semi-constrained
cemented or nonporous uncemented prosthesis, 21
CFR 888.3353
Hip joint femoral (hemi-hip) metal/polymer
cemented or uncemented prosthesis, 21 CFR
888.3390
Hip joint metal/polymer/metal semi-constrained
porous-coated uncemented prosthesis, 21 CFR
888.3358
Hip joint metal/polymer semi-constrained cemented
prosthesis, 21 CFR 888.3350 |
| | Knee joint femorotibial metal/polymer constrained
cemented prosthesis, 21 CFR 888.3510
Knee joint femorotibial metal/polymer semi-
constrained cemented prosthesis, 21 CFR 888.3530
Knee joint femorotibial (uni-compartmental)
metal/polymer porous-coated uncemented
prosthesis, 21 CFR 888.3535 |
| Predicate Devices: | All standard ultra high molecular weight
polyethylene (UHMWPE) components of the
following legacy Centerpulse trade names:
Apollo® Knee System
APR® Hip System
Bipolar Prosthesis
Epsilon™ Acetabular System
MOST® System
Natural-Knee® System
Natural-Knee® II System |
| Device Descriptions: | All standard UHMWPE components of the
following legacy Centerpulse trade names:
Apollo® Knee System
APR® Hip System
Bipolar Prosthesis
Epsilon™ Acetabular System
MOST® System
Natural-Knee® System
Natural-Knee® II System |
| Intended Uses: | 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. |
| Comparison to Predicate Devices: | The proposed devices are identical to the predicate
devices. The packaging for the legacy Centerpulse
standard UHMWPE devices will be changed from
the current packaging to the packaging used for
legacy Zimmer, Inc. UHMWPE device in order to
standardize packaging within Zimmer, Inc. |
| Performance Data (Non-clinical
and/or Clinical): | Non-clinical Performance and Conclusions:
Package configurations for legacy Zimmer Inc. and
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
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