(89 days)
No
The summary describes a mechanical orthopedic implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "treatment option for patients requiring distal femoral replacement," directly indicating its role in therapy for various conditions like tumor resection, osteoarthritis, and correction of deformities.
No
This device is described as an implantable prosthetic component for patients requiring distal femoral replacement, primarily for tumor resection or joint replacement. Its function is to expand as the patient grows, not to diagnose medical conditions.
No
The device is a physical implant (distal femoral expandable knee) and not a software-only medical device. The description focuses on the mechanical aspects and intended use as a surgical implant.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The description clearly states that this device is an implantable prosthesis used for surgical replacement of the distal femur. It is a physical device implanted into the patient's body, not a tool for analyzing biological samples.
The text describes a surgical implant used for treatment, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Biomet Side Access Distal Femoral Expandable offers a treatment option for patients requiring distal femoral replacement who have not yet achieved full skeletal maturity (open epiphysis) or patients who require surgery who have significant residual leg length discrepancy. Indication for use of this device is most commonly tumor resection but could also involve osteoarthritis; rheumatoid arthritis; correction of deformity; and correction or revision of unsuccessful osteotomy, arthrodesis or previous joint replacement.
The devices are single use implants intended for implantation with bone cement or with Biomet Compress®.
Product codes
KRO, HXX
Device Description
The Biomet Side Access Distal Femoral Expandable Knee is an additional component to Biomet's Orthopedic Salvage System (OSS) that gives the surgeon the ability to expand the prosthesis as the patient grows. All expansion takes place where natural bone has been removed. The device does not lengthen existing bones. The expandable device is available in standard and Reduced Size (RS) and is compatible with Biomet OSS system components and Compress (CPS) devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal femoral
Indicated Patient Age Range
patients who have not yet achieved full skeletal maturity (open epiphysis)
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)
Cyclic fatigue was conducted.
Testing verified that the accuracy and performance of the system is adequate to perform as intended and to demonstrate substantial equivalence to the predicate device.
No clinical testing was necessary for a determination of substantial equivalence.
The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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Image /page/0/Picture/2 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and connected, giving the word a solid, block-like appearance. A registered trademark symbol is present to the upper right of the letter "T".
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 .
| Submitter Information | |
|---|---|
| Name | Biomet Manufacturing LLC |
| Address | 56 East Bell Drive |
| Warsaw, IN 46581-0857 | |
| Phone number | (574) 372-1761 |
| Fax number | (574) 372-1683 |
| Establishment | |
| Registration Number | 1825034 |
| Name of contact person | Tracy Bickel Johnson, RAC |
| Date prepared | February 2014 |
| Name of device | |
| Trade or proprietary | |
| name | Biomet Side Access Distal Femoral Expandable |
| Common or usual | |
| name | Constrained knee implant |
| Classification name / | |
| Regulation | Prosthesis, knee, femorotibial, constrained, cemented, |
| metal/polymer (888.3510) | |
| Classification panel | Orthopedic |
| Product Code(s) | KRO |
| Name of accessories | |
| Trade or proprietary | |
| name | Biomet Side Access Expandable Revolution Counter |
| Biomet Side Access Expandable 5mm Straight Hex and Modular | |
| Ball Hex | |
| Common or usual | |
| name | Instrument Specific Instrument- Surgical, Orthopedic Accessory |
| Screwdriver | |
| Classification name / | |
| Regulation | Implant specific Instrument- Prosthesis, knee, femorotibial, |
| constrained, cemented, metal/polymer (888.3510) | |
| Screwdriver (888.4540) | |
| Classification panel | Orthopedic |
| Product Code(s) | KRO |
| HXX | |
| Legally marketed device(s) | |
| to which equivalence is | |
| claimed | Biomet Expandable Knee (Biomet Manufacturing), K020381 |
| Reason for 510(k) submission | New device |
| Device description | The Biomet Side Access Distal Femoral Expandable Knee is an additional component to Biomet's Orthopedic Salvage System (OSS) that gives the surgeon the ability to expand the prosthesis as the patient grows. All expansion takes place where natural bone has been removed. The device does not lengthen existing bones. The expandable device is available in standard and Reduced Size (RS) and is compatible with Biomet OSS system components and Compress (CPS) devices. |
| Intended use of the device | Knee replacement |
| Indications for use | The Biomet Side Access Distal Femoral Expandable offers a treatment option for patients requiring distal femoral replacement who have not yet achieved full skeletal maturity (open epiphysis) or patients who require surgery who have significant residual leg length discrepancy. Indication for use of this device is most commonly tumor resection but could also involve osteoarthritis; rheumatoid arthritis; correction of deformity; and correction or revision of unsuccessful osteotomy, arthrodesis or previous joint replacement. |
| The devices are single use implants intended for implantation with bone cement or with Biomet Compress®. | |
| Summary of the Technologies | The expandable device is available in standard and Reduced Size (RS) and is compatible with all Biomet OSS system components and Compress (CPS) devices. The Biomet Side Access Distal Femoral Expandable knee functions by means of an inner telescoping tube, also called the intercalary segment, which is moved by an adjusting screw that is coaxial with the tube. The expansion is performed in a manner simpler for the patient and the surgeon. |
| PERFORMANCE DATA | |
| SUMMARY OF NON-CLINICAL TESTS | |
| Performance Test Summary-New Device | |
| Cyclic fatigue was conducted. | |
| Testing verified that the accuracy and performance of the system is adequate to perform as intended and to demonstrate substantial equivalence to the predicate device. | |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION | |
| Clinical Performance Data/Information: N/A | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | |
| No clinical testing was necessary for a determination of substantial equivalence. |
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
Image /page/1/Picture/1 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and connected to each other. There is a trademark symbol to the right of the letter "T".
.
The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 28, 2014
Biomet Manufacturing LLC Ms. Tracy Bickel Johnson Regulatory Global Project Manager 56 East Bell Drive Warsaw. Indiana 46581-0857
Re: K140509
Trade/Device Name: Biomet Side Access Distal Femoral Expandable Regulation Number: 21 CFR 888.3510 Regulation Name: Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRO Dated: February 25, 2014 Received: February 28, 2014
Dear Ms. Bickel Johnson:
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 than I 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
3
Page 2 - Ms. Tracy Bickel Johnson
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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/ResourcestorYou/Industry/default.htm.
Sincerely yours,
Lori A. Wigqins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
K140509 510(k) Number:
Device Name: Biomet Side Access Distal Femoral Expandable
Indications For Use:
The Biomet Side Access Distal Femoral Expandable offers a treatment option for patients requiring distal femoral replacement who have not yet achieved full skeletal maturity (open epiphysis) or patients who require surgery who have significant residual leg length discrepancy. Indication for use of this device is most commonly tumor resection but could also involve osteoarthritis; rheumatoid arthritis; correction of deformity; and correction or revision of unsuccessful osteotomy, arthrodesis or previous joint replacement.
The devices are single use implants intended for implantation with bone cement or with Biomet Compress®.
× Prescription Use_ (Per 21 CFR 801 Subpart D)
.
AND/OR Over-the-Counter_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
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Riomet Side Access Distal Femoral Expanduble Traditional 510(k) ነገስ እንደተለ
Biomet Manufacturing, LLC