(126 days)
Not Found
No
The 510(k) summary describes mechanical orthopedic implants and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for use in total knee and hip replacement procedures to alleviate pain, correct deformities, treat non-unions, and revise failed arthroplasties, which are all therapeutic interventions for medical conditions.
No
The document describes joint replacement components (distal femoral and proximal femoral components) and their intended use in surgical procedures to replace parts of the femur, not to diagnose a condition.
No
The device description clearly states it is a physical implant (Segmental Distal Femoral Components and Proximal Femoral Bodies) designed to replace parts of the femur. It is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that these are implants designed to replace parts of the femur (thigh bone) in total knee and hip replacement procedures. They are physical components implanted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a medical implant or surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Biomet's Segmental Distal Femoral Components are intended for use in total knee replacement and the Proximal Femoral Bodies are intended for use in hip replacement procedures. Specific indications for these devices are:
-
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis.
-
- Correction of varus, valgus or post traumatic deformity
-
- Correction of revision of unsuccessful ostectorny, arthrodesis, or previous joint replacement.
-
- Ligament deficiencies
-
- Tumor resections
-
- Treatment of non-unions, femoral neck and trochanteric fracture 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 for use (USA)
When used with Biomet's Compress® Segmental Femoral Replacement System, the indications for use are uncemented application in cases of:
-
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
-
- Tumor resections.
-
- Revision of previously failed total joint arthroplasty.
-
- Trauma.
Product codes (comma separated list FDA assigned to the subject device)
KRO, JDI
Device Description
The Segmental Distal Femoral Components with a Compress® Female Taper are designed to replace the distal end of the femur including the knee articulating surface. The Proximal Femoral Bodies with a Compress® Female Taper are designed to replace the proximal end of the femur including the hip articulating surface. These components are intended for use with Biomet's Compress® Segmental Femoral and Orthopedic Salvage Systems. The new devices that are the subject of this 510(k) have a taper bore that is directly compatible with the taper of the Compress spindle eliminating the need for a taper adapter and allowing for smaller resection lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Distal end of the femur, knee articulating surface, proximal end of the femur, hip articulating surface.
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: None provided as a basis for substantial equivalence.
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.
K043547 & K062998, K002757& K052685
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 ORTHOPEDICS, INC. The word "BIOMET" is in a stylized font with a geometric design. Below the logo, the words "ORTHOPEDICS, INC." are printed in a simple, sans-serif font. The logo appears to be for a company that specializes in orthopedic products or services.
510(k) Summary
JUN 11 2008
March 31, 2008 Preparation Date:
Biomet Manufacturing Corp. Applicant/Sponsor:
Patricia Sandborn Beres Contact Person: Senior Regulatory Specialist
Proprietary Name: Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress® Female Taper
Common Name: Proximal or distal femoral replacement components
Classification Names:
- · Hip Joint. Metal/Polymer, Semi-Constrained, Cemented Prosthesis (21 CFR §888.3350)
- · Knee Joint, Femorotibial, Metal/Polymer Constrained, Cemented Prosthesis (21 CFR $888.3510)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
- · Compress® Segmental Femoral Replacement System K043547 & K062998
- · Orthopedic Salvage System (OSS™) K002757& K052685
Device Description:
The Segmental Distal Femoral Components with a Compress® Female Taper are designed to replace the distal end of the femur including the knee articulating surface. The Proximal Femoral Bodies with a Compress® Female Taper are designed to replace the proximal end of the femur including the hip articulating surface. These components are intended for use with Biomet's Compress® Segmental Femoral and Orthopedic Salvage Systems. The new devices that are the subject of this 510(k) have a taper bore that is directly compatible with the taper of the Compress spindle eliminating the need for a taper adapter and allowing for smaller resection lengths.
Intended Use:
Biomet's Segmental Distal Femoral Components are intended for use in total knee replacement and the Proximal Femoral Bodies are intended for use in hip replacement procedures. Specific indications for these devices are:
-
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis.
-
- Correction of varus, valgus or post traumatic deformity
-
- Correction of revision of unsuccessful ostectorny, arthrodesis, or previous joint replacement.
-
- Ligament deficiencies
Mailing Address Warson 0 16581-0587 Toll Free: 820,348,9500
Shipping Address East Bel Drive Warsan N 46582
1
510(k) Summary
5 North Gammery
Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress® Female Taper March 31, 2008
-
- Tumor resections
-
- Treatment of non-unions, femoral neck and trochanteric fracture 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 for use (USA)
When used with Biomet's Compress® Segmental Femoral Replacement System, the indications for use are uncemented application in cases of:
-
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
-
- Tumor resections.
-
- Revision of previously failed total joint arthroplasty.
-
- Trauma.
Summary of Technologies: The Segmental Distal Femoral Components and Proximal Femoral Bodies with Compress® Female Taper have similar technologies as the predicate devices.
Non-Clinical Testing: None provided as a basis for substantial equivalence.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks of property of Biomet, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 2008
Biomet, Inc. % Ms. Patricia Sandborn Beres Senior Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K080330
Trade/Device Name: Segmental Distal Femoral Components and Proximal Femoral Bodies with Compress® Female Taper Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulation Class: Class II Product Code: KRO, JDI Dated: June 3, 2008 Received: June 6, 2008
Dear Ms. Beres:
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
3
Page 2 - Ms. Patricia Sandborn Beres
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) 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 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 Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millerson
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): K080330
Device Name: Segmental Distal Femoral Components and Proximal Femoral Bodies with Compress® Female Tapers
Biomet's Segmental Distal Femoral Components are intended for use in total knee replacement and the Proximal Femoral Bodies are intended for use in hip replacement procedures. Specific indications for these devices are:
-
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis.
-
- Correction of varus, valgus or post traumatic deformity
-
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
-
- Ligament deficiencies
-
- Tumor resections
-
- Treatment of non-unions, femoral neck and trochanteric fracture 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 for use (USA)
When used with Biomet's Compress Segmental Femoral Replacement System, the indications for use are uncemented application in cases of:
-
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous ioint replacement.
-
- Tumor resections.
-
- Revision of previously failed total joint arthroplasty.
-
- Trauma.
Prescription Use ਮ (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)
NetRp dyler formxm
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K080330
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