(190 days)
Not Found
No
The summary describes a mechanical implant with a spring system and does not mention any computational or data-driven features indicative of AI/ML.
Yes
Explanation: The device is a distal femoral replacement system intended to replace a part of the femur due to tumors or revisions, thereby treating a pathological condition.
No
The device is a Distal Femoral Replacement System, which is an implant used to replace a part of the femur. Its stated use is for tumors and revisions, and it is described as a "metallic femoral segmental fixation stem" and a "prosthetic implant". These descriptions indicate it is a therapeutic device, not one used for diagnosis.
No
The device description explicitly states it is a "metallic femoral segmental fixation stem" and describes a "spring system built into the stem," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to replace the distal part of the femur in cases of severe bone loss due to tumors or revisions. This is a surgical implant, not a test performed on biological samples outside the body.
- Device Description: The device is described as a metallic femoral segmental fixation stem. This is a physical implant for surgical use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a therapeutic implant used in surgery.
N/A
Intended Use / Indications for Use
The ComPreSs™ Distal Femoral Replacement System is indicated for tumors of the distal femur and revisions of oncologic distal femoral replacements.
The ComPreSs™ Distal Femoral Replacement components are intended for uncemented use.
Product codes (comma separated list FDA assigned to the subject device)
KRO
Device Description
The ComPreSs™ Distal Femoral Replacement is a metallic femoral segmental fixation stem intended to replace the distal part of the femur in cases of severe bone loss. The design of the ComPreSs™ stem allows a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. This is accomplished through a spring system built into the stem.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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:
Results of mechanical testing showed that the ComPreSs™ Distal Femoral Replacement produces less stress shielding than a standard cemented implant. Testing also addressed all failure mechanisms for the device, and was found to be strong enough to begin the clinical study.
Clinical Results:
The clinical results determined that the ComPreSs™ Distal Femoral Replacement is substantially equivalent to similar knee prostheses implanted for similar indications.
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
DEC 1 8 2003
page 1 of 2
BIOMET
510 (K) Summary
Applicant or Sponsor:
Biomet, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0578
Contact Person:
Gary Baker Phone: (574) 267-6639 Extension 1568
Proprietary Name: ComPreSs™ Distal Femoral Replacement.
Common Name: Segmental Femoral Stem Component.
Classification: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer (21 CFR §888.3510)
Product Code: KRO
Device Classification: Class II
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Device Description:
The ComPreSs™ Distal Femoral Replacement is a metallic femoral segmental fixation stem intended to replace the distal part of the femur in cases of severe bone loss. The design of the ComPreSs™ stem allows a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. This is accomplished through a spring system built into the stem.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
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()FFFICE 574.267.6639
FAX 574.267.8137
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1
K031804
page 2 of 2
Indications for Use:
The ComPreSs™ Distal Femoral Replacement System is indicated for tumors of the distal femur and revisions of oncologic distal femoral replacements.
The ComPreSs™ Distal Femoral Replacement components are intended for uncemented use.
Summary of Technologies:
The ComPreSs "M Distal Femoral Replacement is made of the same material as the predicate device. Unlike the predicate device, the ComPreSs™ Distal Femoral Replacement components are intended for uncemented use.
Non-Clinical Testing:
Results of mechanical testing showed that the ComPreSs™ Distal Femoral Replacement produces less stress shielding than a standard cemented implant. Testing also addressed all failure mechanisms for the device, and was found to be strong enough to begin the clinical study.
Clinical Results:
The clinical results determined that the ComPreSs™ Distal Femoral Replacement is substantially equivalent to similar knee prostheses implanted for similar indications.
Summary:
Based on the results of mechanical testing and clinical data, the ComPreSs™ Distal Femoral Replacement is substantially equivalent to the predicate device.
All trademarks are 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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2003
Mr. Gary Baker Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K031804
Trade Name: ComPreSs" Distal Femoral Replacement Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO Dated: September 24, 2003 Received: September 25, 2003
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 Amendnents, 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 - Mr. Gary Baker
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 Office of Compliance at (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark A. Milkersen
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO31804 510(k) Number (IF KNOWN):
Device Name: ComPreSs™ Distal Femoral Replacement
Indications for Use:
The ComPreSs™ Distal Femoral Replacement System is indicated for tumors of the distal femur and revisions of oncologic distal femoral replacements.
The ComPreSs™ Distal Femoral Replacement components are intended for uncemented use.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Use ✗
(Per 21 CFR 801.109)
OR
Over-the-Counter Use __
(Optional Format 1-2-96)
vision Sign-On;
"ivision of Ganool Dententi