(77 days)
Not Found
No
The 510(k) summary describes a passive implant (porous titanium sleeve augments) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The device description focuses on the material and mechanical design.
Yes.
The device is indicated for use in treating painful and disabled knee joints resulting from various conditions like osteoarthritis and traumatic arthritis, and for correction or revision of unsuccessful joint replacement procedures, which are therapeutic applications.
No
Explanation: This device is described as an implant used for knee joint replacement and augmentation, which is a therapeutic device, not a diagnostic one. It is used to correct physical deformities and replace bone, not to detect or diagnose medical conditions.
No
The device description clearly states the device is composed of titanium alloy and is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an implant for surgical procedures to address painful and disabled knee joints, deformities, and revisions of previous surgeries. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a porous titanium sleeve augment designed for attachment to knee components and fixation into bone. This is a physical implant, not a reagent, instrument, or system used to examine specimens.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
Therefore, the Regenerex™ Porous Titanium Sleeve Augments are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Regenerex™ Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments) are indicated for use with the following cemented systems: the Vanguard™, Ascent™, and Maxim® knee systems, as well as the Biomet® Tibial Augmentation Components, Stemmed Tibial Components, Offset Tibial Trays and Offset Tibial Tray Adaptors. The Regenerex™ Porous Titanium Sleeve Augments are indicated for use with following uncemented system: the Vanguard™ Non-Cemented Porous Coated Knee Components.
Specific indications are as follows:
- Painful and disabled knee joint resulting from osteoarthritis, 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 are single use implants. Cemented and uncemented applications.
AND
The Regenerex™ Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments) are indicated for use with the OSS™ system.
Specific indications are as follows:
- Painful and disabled knee 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.
- Trauma.
These are single use implants. Cemented applications only.
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH, KRO
Device Description
The Regenerex™ Porous Titanium Sleeve Augments are truncated cones with a centrally located bore that are composed of titanium alloy (Ti-6Al-4V) per ASTM F1580-95 that is approximately 67% porous. The augments are designed for attachment to selected commercially available Biomet® tibial base plates and stemmed femoral components using cement. The devices are intended for fixation into either the proximal tibia or distal femur in cases of severe bone loss.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint, proximal tibia, distal femur
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)
Non-Clinical Testing: Previous non-clinical laboratory testing and engineering justification 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.
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
§ 888.3560 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.
0
Image /page/0/Picture/1 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in a stylized font with a registered trademark symbol. Below that, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font.
510(k) Summary
Preparation Date: October 19, 2007
NOV - 5 2007
Applicant/Sponsor: Biomet Manufacturing Corp.
Contact Person: Becky Earl
Proprietary Name: Regenerex™ Porous Titanium Sleeve Augments
Common Name: femoral and tibial knee augments
Classification Name(s):
- Knee ioint patellofemorotibial polymer semi-constrained cemented prosthesis � (888.3560)
- Knee ioint patellofemorotibial metal/polymer porous-coated uncemented prosthesis (888.3565) ●
- Knee joint femorotibial metal/polymer constrained cemented prosthesis (888.3510) .
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Regenerex™ Knee Augments (Biomet, Inc.)- K053505 and Trabecular Metal™ Tibial and Femoral Cone Augments (Zimmer, Inc.)-K053340
Device Description: The Regenerex™ Porous Titanium Sleeve Augments are truncated cones with a centrally located bore that are composed of titanium alloy (Ti-6Al-4V) per ASTM F1580-95 that is approximately 67% porous. The augments are designed for attachment to selected commercially available Biomet® tibial base plates and stemmed femoral components using cement. The devices are intended for fixation into either the proximal tibia or distal femur in cases of severe bone loss.
Indications for Use:
The Regenerex™ Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments) are indicated for use with the following cemented systems: the Vanguard™, Ascent™, and Maxim® knee systems, as well as the Biomet® Tibial Augmentation Components, Stemmed Tibial Components, Offset Tibial Trays and Offset Tibial Tray Adaptors. The Regenerex™ Porous Titanium Sleeve Augments are indicated for use with following uncemented system: the Vanguard™ Non-Cemented Porous Coated Knee Components.
Specific indications are as follows:
-
- Painful and disabled knee joint resulting from osteoarthritis, 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 are single use implants. Cemented and uncemented applications.
Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587 Toll Free: 800 348.9500 Office: 574.267.6639 Main Fax: 574.267.8137 www.biomet.com
Shipping Address: 56 East Bell Drive Warsaw. IN 46582
1
510(k) Summary Regenerex™ Porous Titanium Sleeve Augments Page 2 of 2
and
The Regenerex™ Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments) are indicated for use with the OSS™ system.
Specific indications are as follows:
-
- Painful and disabled knee 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.
-
- Trauma.
These are single use implants. Cemented applications only.
Summary of Technological The technological characteristics (material modification, design, sizing, indications) of the Regenerex™ Porous Titanium Sleeve Augments are similar to or identical to the predicate devices.
Non-Clinical Testing: Previous non-clinical laboratory testing and engineering justification 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 Trabecular Metal™ which is a trademark of Zimmer, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 2007
Biomet Manufacturing Corp. % Ms. Becky Earl Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
K072336 Re:
Trade/Device Name: Regenerex™ Porous Titanium Sleeve Augments Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH, KRO Dated: October 19, 2007 Received: October 22, 2007
Dear Ms. Earl:
We have reviewed your Section 510(k) premarket notification of intent to market the device wone roterioried your betermined 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 econment to prove 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). and Oosmetic For ( 100 ) 100 year 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 hay of birthe 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. Becky Earl
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) r mo letter notification. The FDA finding of substantial equivalence of your device to a legally premarket noticated 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 in you atence 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 other general mistmance 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 yo
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _K072336
Device Name: Regenerex™ Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments)
The Regenerex™ Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments) are indicated rne regently - " " orders" nemented systems: the Vanguard™, Ascent™, and Maxim® knee systems, as for use with the following comments, Stemmed Tibial Components, Offset Tibial Trays well as the blometer Tibial Aganehallen Corex™ Porous Titanium Sleeve Augments are indicated for use anta Onset Tiblar Tray Hauptorer The Vanguard™ Non-Cemented Porous Coated Knee Components.
Specific indications are as follows:
-
- Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis where one or more compartments are involved.
-
- Correction of varus, valgus, or posttraumatic deformity.
-
- Correction or revision of unsuccessful ostectorny, arthrodesis, or failure of previous joint replacement procedure.
These are single use implants. Cemented and uncemented applications.
| Prescription Use (Part 21 CFR 801 Subpart D) | YES | AND/OR | Over-The-Counter Use (21 CFR 807 Subpart C) | NO |
|---|---|---|---|---|
| ---------------------------------------------- | ----- | -------- | --------------------------------------------- | ---- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (Division Sign-Off)
Division of General, Restorative, Devices
Page 1 of 2
5
Indications for Use
510(k) Number (if known):_K072336
Device Name: Regenerex™ Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments)
The Regenerex™ Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments) are indicated for use with the OSS™ system.
Specific indications are as follows:
-
- Painful and disabled knee joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
-
- Correction of varus, valgus, or posttraumatic deformity.
-
- Correction or varus, values of postfularhed. In the provious joint replacement.
-
- Ligament deficiencies.
-
- Tumor resection.
-
- Trauma.
These are single use implants. Cemented applications only.
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)
Page 2 of 2