(28 days)
The Trabecular Metal Femoral Cone Augments are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. The Trabecular Metal Femoral Cone Augments are for cemented use only in the USA, and for cementless or cemented use outside the USA.
The Trabecular Metal Femoral Cone Augments are to be used in conjunction with Zimmer Inc.'s LCCK and Rotating Hinge Knee femoral components. The subject devices are used to fill femoral cavitary defects encountered when implanting either of these two systems. The design of the augment interface inversely corresponds to the design of an LCCK or Rotating Hinge Knee femoral component. The augment has a rectangular, tapered shape. The opposing sides of the rectangle are longer than the center allowing the sides of the augment to fit into the condyles of the femoral component. The center of the augment is hollow to allow passage of the stem through the center of the cone and into the femoral canal. The augments are fixed to the femoral component with bone cement. The Trabecular Metal Femoral Cone Augments are for cemented use along the bone in the USA, and for cementless or cemented use along the bone outside the USA.
The provided text is a 510(k) summary for the Zimmer Trabecular Metal Femoral Cone Augments. It explicitly states that "Testing of the subject devices were not performed."
Therefore, it is impossible to describe acceptance criteria and a study proving the device meets them from the given document. The submission relies on a comparison to predicate devices and previous testing of the Trabecular Metal material itself to establish substantial equivalence, rather than new performance testing of the augments.
As a result, I cannot provide the requested information, including tables of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, because these data were not included in the provided 510(k) submission.
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K051756
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JUL 2 8 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Trabecular Metal Femoral Cone Augments
| Submitter NameAnd Address: | Zimmer Trabecular Metal Technology, Inc.80 Commerce DriveAllendale, New Jersey 07401-1600 |
|---|---|
| Contact Person: | Marci Halevi |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (973) 829-0825 |
| Date Prepared: | June 30, 2005 |
| Device Trade Name: | Trabecular Metal Femoral Cone Augments |
| Device Common Name: | Knee System Augments |
| Classification Numberand Name: | 21 CFR § 888.3560 Prosthesis, Knee |
The Trabecular Metal Femoral Cone Augments are to be used Device in conjunction with Zimmer Inc.'s LCCK and Rotating Hinge ൗescription: Knee femoral components. The subject devices are used to Rhos remoral cavitary defects encountered when implanting either of these two systems. The design of the augment interface inversely corresponds to the design of an LCCK or Rotating Hinge Knee femoral component. The augment has a rectangular, tapered shape. The opposing sides of the rectangle are longer than the center allowing the sides of the augment to fit into the condyles of the femoral component the dugment to fit the augment to fit over the "box" of the femoral The center of the augment is hollow to allow component. passage of the stem through the center of the cone and into the femoral canal. The augments are fixed to the femoral component with bone cement. The Trabecular Metal Femoral Cone Augments are for cemented use along the bone in the USA, and for cementless or cemented use along the bone outside the USA.
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510(k) Summary (Continued)
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The Trabecular Metal Femoral Cone Augments are Indications for Use: indicated for use in the reconstruction of bony defects in Include reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. The Trabecular Metal Tibial Cone Augments are for cemented use only in the USA, and for cementless or cemented use outside the USA.
A comparison of device technological characteristics and Device Technological properties demonstrates that the device is substantial Characteristics and equivalent to the cited predicate devices. Comparison to Predicate Device: -
Testing of the subject devices were not performed. Performance Data: Previous testing of Trabecular Metal and Trabecular Metal determination of substantial support a devices equivalence.
The Trabecular Metal Femoral Cone Augments are Conclusion: substantially equivalent to the predicate devices (K040630) identified in this premarket notification.
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Image /page/2/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 with three curved lines representing its wings. The eagle is positioned to the right of a circular text element. The text reads "U.S. Department of Health and Human Services, USA" and is arranged around the circumference of the circle.
JUL 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marci Halevi Manager of Regulatory Affairs Zimmer Trabecular Metal Technology, Inc. 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K051756
Trade/Device Name: Trabecular Metal Femoral Cone Augments Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: June 28, 2005 Received: June 29, 2005
Dear Ms. Halevi:
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 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.
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Page 2 - Ms. Marci Halevi
This letter will allow you to begin marketing your device as described in your Section 510(k) I his ictier witi anow you to oegin manag of substantial equivalence of your device to a legally prematication. The Presults 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 11 you desire specific acrieviller - at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Compilance as (= + notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response Assistance at its toll-free number (800) 638-2041 or Manufacturers, meethanomary address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark McMahon
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K051756
Id
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Trabecular Metal Femoral Cone Augments are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. The Trabecular Metal Femoral Cone Augments are for cemented use only in the USA, and for cementless or cemented use outside the USA.
Over-The-Counter Use _ Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark. of Millman
(Division Sign-Off) (Division Sign Of General, Restorative Division ological Devices 510(k) Number -
Page __ of __
(Posted November 13, 2003)
§ 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.