(241 days)
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. Cemented and uncemented applications. The Regenerex™ femoral augments are indicated for use with the Vanguard™ Total Knee System. The Regenerex™ tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.
Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. Correction of varus, valgus, or posttraumatic deformity. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Ligament deficiencies. Tumor Resection. Revision of previously failed total joint arthroplasty. Trauma. These are single use implants. These devices are for cemented use only.
The Regenerex™ Ultra Porous Construct- Titanium Knee Augments are designed for attachment to selected commercially available Biomet® tibial base plates and femoral components using bolts, cement or a combination of both (depending on the augment). The augments are manufactured to interface with selected femoral and tibial Biomet® components. The femoral augments come in nine (9) different sizes that correspond with the sizes of the femoral components. The thickness options for the femoral augments vary from 5mm to 15mm. The tibial augments are available in 10° wedge and block form. The block augments are available in three (3) thicknesses for nine (9) tibial sizes. The OSS femoral augments are available in a 3,5mm thick anterior flange augment. The OSS tibial augments are available in monoblock and block form. The monoblocks are only available in 10mm thicknesses for three tibial sizes, while the block augments are available in 10mm and 20 mm sizes for three tibial sizes.
The provided document is a 510(k) premarket notification for the Regenerex™ Ultra Porous Construct- Titanium Knee Augments. The content primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than providing a detailed study proving the device meets specific performance acceptance criteria.
Therefore, many of the requested details about acceptance criteria, specific study design, and performance metrics are not present in this document. The document states:
"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." (Page 1)
"Clinical Testing: None provided as a basis for substantial equivalence." (Page 1)
This means the submission relies on non-clinical testing and comparison to predicates, not specific clinical performance studies with detailed acceptance criteria as one might find for a novel device requiring more extensive validation.
Given the information provided, here's what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-clinical functionality within intended use (This is a high-level summary, specific granular criteria are not detailed in the document) | "The results indicated that the device was functional within its intended use." (Page 1) |
Missing: Specific quantifiable acceptance criteria (e.g., tensile strength, fatigue life, wear rate thresholds) and the exact numerical performance results for these criteria. The document only provides a general statement of functionality.
2. Sample size used for the test set and the data provenance
Not provided. The document mentions "non-clinical laboratory testing" but does not specify the sample size, type of test specimens, or the provenance of any data used for these tests. It is implied these were laboratory tests on the device itself, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. Since the testing was non-clinical and no clinical data was presented, there was no "ground truth" derived from expert review of patient data in the context of this 510(k) submission.
4. Adjudication method for the test set
Not applicable/Not provided. No clinical test set requiring adjudication by experts was presented.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This device is a medical implant (knee augments), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. As mentioned above, this is a physical implant, not an algorithm.
7. The type of ground truth used
For the non-clinical testing, the "ground truth" would be established by standard engineering and material science specifications, predicate device performance data, and regulatory standards for mechanical and material properties of implants. However, the document does not detail these specific standards or how the device's performance compared against them. It only states it was "functional within its intended use."
8. The sample size for the training set
Not applicable/Not provided. There is no "training set" in the context of this 510(k) submission as it is not a machine learning/AI device.
9. How the ground truth for the training set was established
Not applicable/Not provided. As above, no training set was involved.
In summary: The provided 510(k) notification for the Regenerex™ Ultra Porous Construct- Titanium Knee Augments relies heavily on a comparison to predicate devices and general non-clinical laboratory testing to assert substantial equivalence. It does not contain the detailed performance data, acceptance criteria, sample sizes for patient data, or expert review methodologies that would be typical for clinical studies validating a new diagnostic or AI-driven device. The statement "Clinical Testing: None provided as a basis for substantial equivalence" is key in understanding the limited scope of detailed performance data in this particular document.
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K053575 1/2
Image /page/0/Picture/1 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are outlined in black, with the interior of the letters being white. The letters are all capitalized and evenly spaced. The overall impression is one of a strong, modern logo.
AUG 1 4 2006
Applicant/Sponsor: Biomet Manufacturing Corp.
Contact Person: Tracy Bickel Johnson, RAC
Proprietary Name: Regenerex™ Ultra Porous Construct- Titanium Knee Augments
Common Name: Knee Augments
Classification Name: - prosthesis, knee, patello/femorotibial, semi-constrained, cemented, polymer/metal/polymer (888.3560) -prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer (888.3565) -prosthesis, knee, femorotibial, constrained, cemented, metal/polymer (888.3510)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Maxim® Accel Knee System- K023546 (Biomet, Inc.); MCK Knee System- K915132 (Biomet, Inc.); Trabecular Metal Knee System Augments- K040487 (Zimmer Holdings); NexGen Complete Knee Solution Trabecular Metal- K024161 (Zimmer Holdings); Oncology Salvage System- K002757 (Biomet, Inc.)
Device Description: The Regenerex™ Ultra Porous Construct- Titanium Knee Augments are designed for attachment to selected commercially available Biomet® tibial base plates and femoral components using bolts, cement or a combination of both (depending on the augment).
The augments are manufactured to interface with selected femoral and tibial Biomet® components. The femoral augments come in nine (9) different sizes that correspond with the sizes of the femoral components. The thickness options for the femoral augments vary from 5mm to 15mm. The tibial augments are available in 10° wedge and block form. The block augments are available in three (3) thicknesses for nine (9) tibial sizes. The OSS femoral augments are available in a 3,5mm thick anterior flange augment. The OSS tibial augments are available in monoblock and block form. The monoblocks are only available in 10mm thicknesses for three tibial sizes, while the block augments are available in 10mm and 20 mm sizes for three tibial sizes.
Intended Use:
Femoral and Tibial Augments are intended for:
- Painful and disabled knee joint resulting from osteoarthritis, theumatoid arthritis, traumatic arthritis 1. 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.
Cemented and uncemented applications
The Regenerex™ femoral augments are indicated for use with the Vanguard™ Total Knee System.
The Regenerex™ tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.
MAILING ADDRESS 19 - P.O. Box 587
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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
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()FFICE: 574.267.6639
I·AX 574.267.8137
E-MAIL biomet@biomet.com
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Image /page/1/Picture/0 description: The image shows handwritten text that appears to be a combination of letters and numbers. The text includes 'K653525' followed by '2/2'. The handwriting is somewhat stylized, with some characters slightly distorted or connected.
510(k) Summary Biomet Manufacturing Corp. Regenerex™ Ultra Porous Construct- Titanium Knee Augments
The OSS Augments are intended for:
-
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis
-
- Correction of varus, valqus, or posttraumatic deformity
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
-
- Ligament deficiencies
-
- Tumor Resection
-
- Revision of previously failed total joint arthroplasty
-
- Trauma
These are single use implants These devices are for cemented use only
Summary of Technologies: The technological characteristics (material modification, design, sizing, indications) of the Regenerex™ Ultra Porous Construct- Titanium Knee Augments are similar to 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 Biomet, Inc. except for Hedrocel® and Tantalum, which are property of Zimmer Vinglex Corp.)
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Image /page/2/Picture/12 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three lines forming its wings and body. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Manufacturing, Inc % Ms. Tracy Bickel Johnson, RAC Manager, Regulatory Affairs P.O. Box 587 Warsaw, Indiana 46581-0587
Received: May 16, 2006
AUG 1 4 2006
Re: K053505
Trade/Device Name: Regenerex™ Ultra Porous Construct -- Titanium OSS Knee Augments Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, KRO, JWH Dated: May 15, 2006
Dear Ms. Johnson:
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. This letter will allow you to begin marketing your device as described in your Section 510(k)
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Page 2 - Ms. Tracy Bickel Johnson, RAC
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) 276-0210 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/cdrh/industry/support/index.html.
Sincerely yours.
Barbara Buell
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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K053505 (1)/2
Indications for Use
510(k) Number (if known):
Device Name: Regenerex™ Ultra Porous Construct- Femoral and Tibial Knee Augments
Indications For Use:
- 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 previous ന് joint replacement procedure.
Cemented and uncemented applications
The Regenerex™ femoral augments are indicated for use with the Vanguard™ Total Knee System.
The Regenerex™ tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.
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)
Soubrie buclund to oul.
Division of General, Restorative, and Neurological Devices
510(k) Number K053505
Page 1 of 2
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Ko 53505 (2)/2
Indications for Use
510(k) Number (if known):
Device Name: Regenerex™ Ultra Porous Construct- Titanium OSS Knee Augments
Indications For Use:
-
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis
-
- Correction of varus, valgus, or posttraumatic deformity.
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
-
- Ligament deficiencies
-
- Tumor Resection
-
- Revision of previously failed total joint arthroplasty
-
- Trauma
These are single use implants These devices are for cemented use only
Prescription Use × (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 Device Evaluation (ODE)
Soubare Buelum
Division of General, Restorative, and Neurological Devices
Page 2 of 2
510(k) Number K053505
§ 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.