(88 days)
No
The summary describes passive implants (cone augments) and does not mention any computational or analytical functions, let alone AI/ML.
Yes
The device is described as "augment" components used in total knee arthroplasty to treat severe degeneration, trauma, or other pathology of the knee joint, which falls under the definition of a therapeutic intervention.
No
This device is an implantable augment for total knee arthroplasty, not a diagnostic tool.
No
The device description clearly states that the device is a physical implant (Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments) used in knee arthroplasty, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of donations of blood and tissue with potential recipients, or to monitor therapeutic measures.
- Device Description: The provided text describes a medical device (Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments) that is implanted into the human body during total knee arthroplasty.
- Intended Use: The intended use is to address severe degeneration, trauma, or other pathology of the knee joint by being used with specific knee replacement systems. This is a surgical intervention, not an in vitro examination of specimens.
The device is a surgical implant, not a diagnostic tool used outside the body with biological samples.
N/A
Intended Use / Indications for Use
Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Auqments and Trabecular Metal Femoral Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are for cementless or cemented use.
Product codes
MBH, JWH
Device Description
The Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Auaments are manufactured to be compatible for use with Zimmer's NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System and Zimmer's NexGen Complete Knee Solution - Legacy Knee Constrained Condylar Knee (LCCK) System. When used with the RHK System. the Trabecular Metal Cone Augments are for cemented use only. When used with the LCCK System, the Trabecular Metal Augments are for either cementless or cemented use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The predicate and subject devices are identical; performance characteristics therefore remain as documented in the predicate submission (K031962 and K051756).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K031962, K051756, K040487, K031462
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
K05334o
Zimmer Trabecular Metal Technology, Inc.
FEB 2 1 2006
Trabecular Metal Tibial and Femoral Cone Augments Cemented or Cementless Use 510(k) Premarket Notification
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Trabecular Metal Knee System Augments
-
Submitter Name: Zimmer Trabecular Metal Technology, Inc. Submitter Address: 80 Commerce Drive Allendale, New Jersey 07401-1600 Contact Person(s): Marci Halevi Phone Number: (201) 818-1800 ext 507 Fax Number: (973) 829-0825 Date Prepared: November 28, 2005 Device Trade Name: Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments Device Common Name: Knee System Augments Classification Name: knee, patello/femorotibial, semi-constrained. Prosthesis, uncemented, porous, coated, polymer/metal/polymer
Substantial Equivalence: The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. determination of substantial র্ব equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts. -
Predicate Devices: Trabecular Metal Tibial Cone Augments (K031962) Trabecular Metal Femoral Cone Augments (K051756), Trabecular Metal Knee System Augments (K040487) NexGen Knee System Uncemented Components (K031462).
1
053340
Zimmer Trabecular Metal Technology, Inc
510(K) Summary of Safety and Effectiveness - Continued...
Device Description: The Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Auaments are manufactured to be compatible for use with Zimmer's NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System and Zimmer's NexGen Complete Knee Solution - Legacy Knee Constrained Condylar Knee (LCCK) System. When used with the RHK System. the Trabecular Metal Cone Augments are for cemented use only. When used with the LCCK System, the Trabecular Metal Augments are for either cementless or cemented use.
Intended Use: Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are for cementless or cemented use.
- Performance Data: The predicate and subject devices are identical; performance characteristics therefore remain as documented in the predicate submission (K031962 and K051756).
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged around the seal's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2006
Zimmer Trabecular Metal Technology, Inc. c/o Ms. Marci Halevi Manager of Regulatory Affairs 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K053340
Trade/Device Name: Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments
Regulation Number: 21 CFR 888.3565 and 21 CFR 888.3560
Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis, Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis
Regulatory Class: II Product Code: MBH, JWH Dated: November 30, 2005 Received: December 1, 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
3
Page 2 - Ms. Halevi
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 CMR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
fo
Mark N. Melkerson, M.S. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use KOS 3340 510(k) Number (if known):
Device Name: Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments
Indications for Use:
Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Tibial Cone Auqments and Trabecular Metal Femoral Cone Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments are for cementless or cemented use.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
Helbert Lumio
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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| œ | C | |
|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
(Posted November 13, 200510(k) Number_