(106 days)
Not Found
No
The document describes a system of modular orthopedic implants and the testing performed on them. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is described as "Biomet's Segmental Femoral Replacement components are intended for use in total knee, total hip, or total femoral replacement procedures" and "The Orthopedic Salvage System is a system of modular components that are intended to be used for difficult revision surgeries or limb salvage procedures." These procedures are therapeutic interventions aimed at treating medical conditions.
No.
The device components are intended for use in total knee, total hip, or total femoral replacement procedures and limb salvage surgeries, which are therapeutic interventions rather than diagnostic processes.
No
The device description explicitly states it is a "system of modular components" intended for surgical procedures, and the performance studies describe mechanical testing (fatigue, static axial separation) of physical components (tapers). This indicates a hardware-based medical device.
Based on the provided information, 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, tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly state that this device is a system of modular components intended for surgical implantation to replace portions of or the entire femur and/or the knee and proximal tibia. This is a surgical implant, not a device used for testing biological samples.
- Lack of IVD Characteristics: The document does not mention any testing of biological samples, analysis of biomarkers, or any other activities associated with in vitro diagnostics.
Therefore, the Biomet's Segmental Femoral Replacement components and the Orthopedic Salvage System are surgical implants, not IVDs.
N/A
Intended Use / Indications for Use
Biomet's Segmental Femoral Replacement components are intended for use in total knee, total hip, or total femoral replacement procedures. Specific indications are:
-
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
-
- Correction of varus, valgus or post-traumatic deformity.
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
-
- Ligament deficiencies.
-
- Tumor resections.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femirr with head involvement, unmanageable by 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 for use (USA).
*Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.
When components of the Orthopedie Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, there intended for uncemented application and indicated for:
- Correction or revision of unsucessful osteotomy, arthrodesis, or previous joint replacement.
-
- Tumor resections.
-
- Revision of previously fuiled total joint arthroplasty.
-
- Traumu
Product codes (comma separated list FDA assigned to the subject device)
JDI, KRO
Device Description
The Orthopedic Salvage System is a system of modular components that are intended to be used for difficult revision surgeries or limb salvage procedures. The components can replace any portion of, or the total femur and/or the knee and proximal tibia.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur, Knee, Proximal Tibia, Hip 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)
Non-Clinical Testing:
Cantilever Fatigue testing was conducted to evaluate the taper cantilever fatigue strength and compare the results with the cantilever fatigue strength of the predicate tapers. Results determined that the roller hardened tapers were stronger in cantilever fatigue than the predicate tapers. The acceptance criteria were met.
Compressive Fatigue testing was conducted to evaluate the taper compressive fatigue strength and compare the results with the compressive fatigue strength of the predicate tapers. Results determined that the compressive fatigue strength of the roller hardened tapers was equivalent to or greater than the compressive fatigue strength of the predicate tapers. The acceptance criteria were met.
Static Axial Separation testing was conducted to evaluate the pull-off strength of the taper junction and compare the results with the pull-off strength of the taper junction of the predicate tapers. Results determined that the pull-off strength of the roller hardened tapers was equivalent to or greater than the pull-off strength of the predicate tapers. The acceptance criteria were met.
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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in a stylized font with a thick outline. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font. The text is black and the background is white.
K12350 (pg 1/3)
FEB 2 7 2013
510(k) Summary
Preparation Date:
23 October, 2012
Applicant/Sponsor: Biomet Manufacturing Corp. 56 East Bell Drive Warsaw, IN 46582 FDA Registration #: 1825034
Contact Person:
Gary Baker Sr. Regulatory Specialist 56 East Bell Drive Warsaw, IN 46582 574-267-6639 Ext. 1568 574-371-1027 gary.baker@biomet.com
Proprietary Name:
· Orthopedic Salvage System (OSS)
Constrained knee Common Name:
Classification Code(s)/Name(s): JDI, KRO
888.3350 (JDI) - Hip joint metal/polymer semi-constrained cemented prosthesis.
888.3510 (KRO) - Knee joint femorotibial metal/polymer constrained cemented prosthesis
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
K002757 - Oncology Salvage System (Biomet)
Device Description:
The Orthopedic Salvage System is a system of modular components that are intended to be used for difficult revision surgeries or limb salvage procedures. The components can replace any portion of, or the total femur and/or the knee and proximal tibia.
Intended Use:
The Orthopedic Salvage System components are intended for cemented use only unless used in a proximal femoral replacement application.
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
1
Indications For Use:
Biomet's Segmental Femoral Replacement components are intended for use in total knee, total hip, or total femoral replacement procedures. Specific indications are:
-
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
-
- Correction of varus, valgus or post-traumatic deformity.
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
-
- Ligament deficiencies.
-
- Tumor resections.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by 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 for use (USA).
*Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.
When components of the Orthopedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, they are intended for uncemented application and indicated for:
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
-
- Tumor resections.
-
- Revision of previously failed total joint arthroplasty.
-
- Trauma.
Summarv of Technologies:
The modifications proposed within this submission include expanding the product line and modifying the male tapers from a machined taper to a roller hardened and machined taper.
Non-Clinical Testing:
Cantilever Fatigue testing was conducted to evaluate the taper cantilever fatigue strength and compare the results with the cantilever fatigue strength of the predicate tapers. Results determined that the roller hardened tapers were stronger in cantilever fatigue than the predicate tapers. The acceptance criteria were met.
Compressive Fatigue testing was conducted to evaluate the taper compressive fatigue strength and compare the results with the compressive fatigue strength of the predicate tapers. Results determined that the compressive fatigue strength of the roller hardened tapers was equivalent to or greater than the compressive fatigue strength of the predicate tapers. The acceptance criteria were met.
2
K123501 (pg 3/3)
Static Axial Separation testing was conducted to evaluate the pull-off strength of the taper junction and compare the results with the pull-off strength of the taper junction of the predicate tapers. Results determined that the pull-off strength of the roller hardened tapers was equivalent to or greater than the pull-off strength of the predicate tapers. The acceptance criteria were met.
Clinical Testing:
Clinical testing was not required to demonstrate substantial equivalence of the design modifications proposed to the cleared predicate devices.
All trademarks are property of Biomet, Inc.
3
Image /page/3/Picture/1 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The text is in all caps and is in a sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2013
Biomet Manufacturing Corp. % Mr. Gary Baker Senior Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46582
Re: K123501
Trade/Device Name: Orthopedic Salvage System Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI, KRO Dated: January 11, 2013 Received: January 28, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Gary Baker
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ErinI.D.Keith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _______K123501
Device Name: Orthopedic Salvage System
Indications for Use:
Biomet's Segmental Femoral Replacement components are intended for use in total knee, total hip, or total femoral replacement procedures. Specific indications are:
-
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
-
- Correction of varus, valgus or post-traumatic deformity.
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
-
- Ligament deficiencies.
-
- Tumor resections.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femirr with head involvement, unmanageable by 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 for use (USA).
*Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.
When components of the Orthopedie Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, there intended for uncemented application and indicated for:
- Correction or revision of unsucessful osteotomy, arthrodesis, or previous joint replacement.
-
- Tumor resections.
-
- Revision of previously fuiled total joint arthroplasty.
-
- Traumu
Prescription Use _ YES __ AND/OR Over-The-Counter Use NO NO ____(Part (21 CFR 807 Subpart C) 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabethi i Mrank -S
Division of Orthopedic Devices
10
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