(300 days)
Not Found
No
The document describes a knee implant system and its intended use, focusing on materials and compatibility with existing systems. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities. The performance study section explicitly states the device is identical to the predicate, which also does not suggest AI/ML.
Yes
The device is intended for use in total knee arthroplasty to address severe degeneration, trauma, or other pathology of the knee joint, which indicates it is used to treat or alleviate a medical condition.
No
Explanation: The device description clearly states it is an augmentation system for total knee arthroplasty, indicating it is an implant used in treatment rather than a tool for diagnosis.
No
The device description explicitly states it is a "Trabecular Metal Knee System Augment," which are physical implants made of metal, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (knee system augments) intended for use in total knee arthroplasty. It is a physical device implanted into the body to replace or augment a damaged knee joint.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples, perform tests, or provide diagnostic information about a patient's condition based on biological samples.
The device is a medical device, specifically a surgical implant, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Trabecular Metal Knee System 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 Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use.
Product codes (comma separated list FDA assigned to the subject device)
MBH
Device Description
The Trabecular Metal Knee System Augments 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 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 (K024161).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Implex Corp
DEC 2 1 2004
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Trabecular Metal Knee System Augments
| Submitter Name: | Implex Corp. |
|---|---|
| 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: | February 23, 2004 |
| Device Trade Name: | The Trabecular Metal Knee System Augments |
| Device Common Name: | Knee System Augments |
| Classification Name: | Prosthesis, knee, patello/femorotibial, semi-constrained, |
| 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 |
A determination of substantial reclassification. 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: The NexGen Trabecular Metal Knee System Augments (K024161).
1
510/K) Summary of Safety and Effectiveness - Continued...
- System Augments Metal Knee are Device Description: The Trabecular 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) When used with the RHK System, the Trabecular System. Metal Augments are for cemented use only. When used with the LCCK System, the Trabecular Metal Augments are for either cementless or cemented use.
- Trabecular Metal Knee System Augments are intended for Intended Use: 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 Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use.
- The predicate and subject devices are identical; performance Performance Data: characteristics therefore remain as documented in the predicate submission (K024161).
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other. The faces are connected by a flowing line that resembles a ribbon or wave.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2004
Marci Halevi Manager of Regulatory Affairs Implex Corp. 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K040487
Trade/Device Name: Trabecular Metal Knee System Augments Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal / polymer porous- coated uncemented prosthesis Regulatory Class: II Product Code: MBH Dated: September 22, 2004 Received: September 23, 2004
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.
3
Page 2 - Marci Halevi
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 11 you a this 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/dsma/dsmamain.html
Sincerely yours,
Alan Watts
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Implex Corp
510(k) Number (if known):
Device Name:
Trabecular Metal Knee System Augments
Indications For Use:
Trabecular Metal Knee System Augments are intended for use where severe Trabookal Motar Knoo Or other pathology of the knee joint indicates total knee When used with the NexGen Complete Knee Solution - Rotating arthroplasty. Hinge Knee (RHK) System, the Trabecular Metal Augments are for cemented use Hingo Nhoo (Firm) Cyclen NexGen Complete Knee Solution - Legacy Constrained only. When assuments the Trabecular Metal Augments are for cementless or cemented use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
| Prescription | |
|---|---|
| Use | |
| (Per 21 CFR 801.109) |
OR...
Over-The-Counter Use
(Optional Format 1-2-96)
Division Division of General, Restorative, and Neurological Devices
KO40487 510(k) Number.