(70 days)
The indications for the Regenerex™ Tibial Components include:
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
These devices are single-use implants intended for cemented or uncemented applications.
The Regenerex™ Tibial Components are intended for primary knee arthroplasty and utilize the existing Biomet tibial tray profile and sizing system.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Regenerex™ Tibial Components:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the submission is a 510(k) for substantial equivalence, not a de novo submission presenting novel acceptance criteria. Therefore, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The performance is assessed against the established safety and effectiveness of the predicates.
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (in terms of safety and effectiveness) | Claimed: "The technological characteristics (material, design and sizing) of the Regenerex™ Tibial Components are similar or identical to the predicate devices." Demonstrated via: Non-clinical laboratory testing. Result: "The results indicated that the device was functional within its intended use." |
| Functional within Intended Use | "The results indicated that the device was functional within its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) summary. The submission relies on non-clinical (laboratory) testing for "substantial equivalence" rather than a clinical "test set" from patients.
- Data Provenance: Not applicable, as no human clinical data (prospective or retrospective) from specific countries are mentioned for evaluation of the device's performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. No clinical test set with ground truth established by experts is described. The evaluation was primarily non-clinical.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." Therefore, no MRMC study was conducted, and no effect size for human readers with/without AI assistance can be determined.
6. Standalone Performance Study (Algorithm Only)
Not applicable. The device described (Regenerex™ Tibial Components) is a medical implant, not an AI algorithm. There's no mention of an algorithm or standalone performance testing for AI. The "non-clinical testing" mentioned refers to laboratory tests on the physical implant.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic or AI systems is not directly relevant here. For a physical implant, "ground truth" would be inherent in the physical and mechanical properties demonstrated through laboratory testing (e.g., material strength, wear resistance, dimensional accuracy) against established industry standards or predicate device specifications. The document implies performance was compared against the "intended use" and "predicate devices."
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set."
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APR 2 1 2008
Image /page/0/Picture/2 description: The image shows the BIOMET logo. The logo is in black and white and features the word "BIOMET" in a bold, sans-serif font. The letters are connected to each other, and the logo has a registered trademark symbol. The logo is simple and modern.
MANI ਼ੁਕਤਾਰ
510(k) Summary
| Preparation Date: | April 10, 2008 |
|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corp. |
| Contact Person: | Susan Alexander |
| Proprietary Name: | Regenerex™ Tibial Components |
| Common Name: | Tibial components |
| Classification Name: | Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis (21 CFR §888.3565) |
| Product Code: | MBH JWH |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
| Regenerex™ Ultra Porous Construct-Femoral and TibialKnee Augments | K053505 | Biomet Manufacturing Corp. |
|---|---|---|
| Biomet's Non-Cemented Porous Knee Components | K033489 | Biomet Manufacturing Corp. |
| Trabecular Metal Tibial and Patellar Components for theNexGen® Knee System | K031462 | Zimmer/Implex Corporation |
| AGC® Revision Knee Prosthesis | K033489K912245 | Biomet, Inc. |
| Kirschner Performance Total Knee System Porous Coated | K874547 | Kirschner Medical Corporation |
Device Description: The Regenerex™ Tibial Components are intended for primary knee arthroplasty and utilize the existing Biomet tibial tray profile and sizing system.
Intended Use: Cemented or Uncemented
Indications for Use:
The indications for the Regenerex™ Tiblal Components include:
- Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis, traumatic arthritis where one 1. or more compartments are involved.
-
- Correction of varus, valgus or posttraumatic deformlty.
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
These devices are single-use Implants intended for cemented or uncemented applications.
Malling Address: P.O. Box 597 Warsau, IN 46581-0581 Tel Fres 800 349 9500 Bire 172 2017 00 38 Martist 574 267 8131 www.bomel (00)
Shipping Address: SA FORT Post Daire Warship IN 26557
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KOBO361 Lpa 2123
510(k) Summary Regenerex™ Tibial Components Biomet Manufacturing Corp. Page 2 of 2
Summary of Technological The technological characteristics (material, design and sizing) of the Regenerex™ Tibial Components are similar or Identical to the predicate devices.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Blomet, Inc., except the following: NexCient is a registered trademark of Zimmer, Inc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The text is in all caps and is relatively small compared to the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2008
Biomet Manufacturing Com % Ms. Susan Alexander 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581
K080361 Re: Trade/Device Name: Regenerex™ Tibial Components Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prothesis Regulatory Class: Class II Product Code: MBH, JWH Dated: February 8, 2008 Received: February 11, 2008
Dear Ms. Alexander:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stared in the May 28, 1976, the enactment date of the Medical Device Amendments, or to connifered pror to 1125 20, 1970, the accordance with the provisions of the Federal Food, Drug, devices that have boon formsoned require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, inains 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 If your device to such additional controls. Existing major regulations affecting your device can inay oe subject to back acceral Regulations, Title 21, Parts 800 to 898. In addition, FDA may ov loand in further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 loase be deviloed that i Dr breasan that your device complies with other requirements of the Act that 1127 has Internet and regulations administered by other Federal agencies. You must or any I coural butther and equirements, including, but not limited to: registration and listing (21 comply with an the Hot 3 requirements) 110; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the qualisy by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Susan Alexander
This letter will allow you to begin marketing your device as described in your Section 510(k) promarket 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KOBO361 (Fall)
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Regenerex™ Tibial Components
Indications For Use:
The indications for the Regenerex™ Tibial Components include:
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, 1. traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus or posttraumatic deformity. 2.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of 3. previous joint replacement procedure.
These devices are single-use implants intended for cemented or uncemented applications.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil RP Ogden Exam
(Division Sign-Of Division of General, Restorative, and Neurological Devices
510(k) Number K080361
Page 1 of 1
§ 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.