(52 days)
Not Found
No
The document describes a change in material for a tibial body component of a knee implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended to treat painful and disabled knee joints, correct deformities, and revise failed joint replacements, all of which are therapeutic purposes.
No
The provided text describes a medical device used for the treatment and revision of painful and disabled knee joints, as well as for trauma and tumor resections. It is a physical implant (tibial bodies made from Co-Cr-Mo alloy) intended for surgical procedures, not for identifying diseases or conditions.
No
The device description clearly states it is a physical implant (tibial bodies made from Co-Cr-Mo alloy) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to the surgical treatment and replacement of damaged knee and proximal femur joints. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as "9cm resection tibial bodies" made from a metal alloy. This is a physical implant, not a reagent, instrument, or system used to examine specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
The device is clearly a surgical implant intended for orthopedic procedures.
N/A
Intended Use / Indications for Use
- 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 failure of previous joint replacement.
- Ligament deficiencies.
- Tumor resections.
- Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed total joint arthroplasty.
- Trauma
These devices are to be used with bone cement unless a proximal femur is indicated (USA).
Not applicable to Regenerex Ultra Poreus Construct titanium knee augment usage, or any other knee component.
Product codes (comma separated list FDA assigned to the subject device)
KRO
Device Description
9cm resection tibial bodies
The OSS 9cm Tibial Bodies are being modified to be made from Co-Cr-Mo Cobalt Chrome alloy rather than Ti-6Al-4V titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint, proximal 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 was not considered necessary to establish substantial equivalence to the predicate device(s).
Clinical testing was not considered necessary to establish substantial equivalence to the predicate device(s).
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
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. 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 bold, stylized font with a registered trademark symbol. Below that, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font.
: 、
ン
:
FEB 1 3 2009
| 510(k) Summary | |
|---|---|
| Preparation Date: | 22 December, 2008 |
| Applicant/Sponsor: | Biomet Manufacturing Corp. |
| Contact Person: | Gary Baker, MS RAC |
| Regulatory Specialist | |
| P.O. Box 587 | |
| Warsaw, IN 46581-0587 | |
| Tel: 574-267-6639 Ext. 1568 | |
| Fax: 574-372-1683 | |
| e-mail: gary.baker@biometmail.com | |
| Proprietary Name: | OSS 9cm Cobalt Chrome Tibial Bodies |
| Common Name: | Knee System Tibial bodies. |
| Classification Code(s)/Name(s): | KRO |
| Knee joint femorotibial metal/polymer constrained cemented | |
| prosthesis. 21 CFR §888.3510. | |
| Legally Marketed Devices To | |
| Which Substantial Equivalence | |
| Is Claimed: | Oncology Salvage System - K002757 |
| "System name was changed to Orthopedic Salvage System | |
| Device Description: | 9cm resection tibial bodies |
| Intended Use: | 1. 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 failure of previous joint replacement. - Ligament deficiencies. |
Mailing Address:
P.O. Box 587
Warsaw, IN 46581-0587 Toll Free: B00.348.9500 Office: 574.267.6639
Main Fax: 574.267.8137 www.biomet.com
Shipping Address: 56 East Bell Drive Warsaw, IN 46582
Attachment 6 - Page 1
1
-
- Tumor resection.
-
- Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total joint arthroplasty.
-
- Trauma
These devices are to be used with bone cement unless a proximal femur is indicated (USA).
*Not applicable to Regenerex™ Ultra Porous Construct titanium knee augment usage, or any other knee component.
The OSS 9cm Tibial Bodies are being modified to be made from Co-Cr-Mo Cobalt Chrome alloy rather than Ti-6Al-4V titanium alloy.
Non-clinical testing was not considered necessary to establish substantial equivalence to the predicate device(s).
Clinical testing was not considered necessary to establish substantial equivalence to the predicate device(s).
Summary of Technologies:
Non-Clinical Testing:
Clinical Testing:
All trademarks are property of Biomet, Inc.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2009
Biomet Manufacturing Corp. % Gary Baker, MS, RAC Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K083827
Trade/Device Name: OSS 9cm Cobalt Chrome Tibial Bodies
Regulation Number 21 CER 888:3510 ,
Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulation Class: Class II Product Code: KRO Dated: January 20, 2009 Received: January 22, 2009
Dear Mr. Baker:
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 - Gary Baker, MS, RAC
Enclosure
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 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 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,
Mark N. Mcllerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
Page 1 of 1
Device Name: OSS 9cm Cobalt Chrome Tibial Bodies ...
Indications For Use: .
-
- 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 failure of previous joint ತಿ.. replacement.
-
- Ligament deficiencies.
-
- Tumor resections.
- Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the 6. proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total joint arthroplasty.
-
- Trauma
These devices are to be used with bone cement unless a proximal femur is indicated (USA).
Not applicable to Regenerex " Ultra Poreus Construct titanium knee augment usage, or any other knee component.
Prescription Use YES (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)
Merle A. Milliken
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number
510(k) Number K083827
Attachment 2 - Page I