(90 days)
No
The device description focuses on mechanical components and expansion mechanisms, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is described as a "treatment option" and is indicated for conditions like tumor resection, osteoarthritis, and rheumatoid arthritis, clearly demonstrating its role in treating medical conditions.
No
The device is an implantable prosthesis designed to replace the distal femur and allow for growth/expansion, not to diagnose a condition.
No
The device description clearly describes a physical implantable medical device made of hardware components (expandable segments, stems, etc.) intended for surgical implantation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is an implant intended for surgical implantation within the body to replace a portion of the distal femur.
- Intended Use: The intended use is for surgical treatment of patients requiring distal femoral replacement due to various conditions. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
Therefore, the Expandable Knee is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Expandable Knee 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.
Product codes
KRO
Device Description
The Expandable Knee is an additional component to Biomet's Oncology Salvage System that qives the surgeon the ability to expand the prosthesis as a patient grows. All expansion takes place where the natural bone has been removed. The device does not "lengthen" existing bones.
The devices are available in two styles or expansion mechanisms: a clip-style and a screw-style. The clip-style is available as either a one-piece unit with an integrated distal femoral surface or as a diaphyseal segment for use with the distal femoral replacement component of Biomet's Oncology Salvage System constrained knee system. Clip-style devices are available in 7 initial replacement lengths of 13cm to 19cm providing an additional expansion from 3cm to 9cm. The screw-style expandable segment relies on movement of a screw for expansion. The device has an integrated distal femoral component. The screw-style Expandable Knee is available in 11 sizes providing a maxim expansion from 3cm to 13cm. A series of intramedually stems form 9mm to 19mm in diameter are available for cemented fixation of the remaining femoral bone. In addition to a set number of sizes, Biomet will offer customized components designed to more closely match patient anatomy. These components will be designed within a predefined envelope.
All types of expandable components are intended for use with components of Biomet's Oncology Salvage System.
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 requiring distal femoral replacement 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)
Non-Clinical Testing: Mechanical analysis of both the screw-type and clip-type Expandable Knee has been conducted. Analysis showed that the strength of the expandable devices exceeds that of the clinically success predicate Finn® Knee device. Fatigue testing of the screw-type (worst-case) device has been conducted. This testing showed that the screw mechanism could successfully withstand anatomic loading conditions at maxim expansion. The testing also demonstrated that the expansion mechanism remained functional after fatigue.
Clinical Testing: None provided
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
MAY 0-6 2002
020381
page 1 of 2
CORPOR ARTERS
Summary of Safetv and Effectiveness
Applicant/Sponsor:Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
- Contact Person: Patricia Sandborn Beres Senior Requlatory Specialist Telephone: (574) 267-6639 Fax: (574) 372-1683
Proprietary Name: Expandable Knee
Common Name: Knee replacement prosthesis
Classification Name: Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer (888.3510)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Substantial equivalence is claimed to Biomet's Finn® Knee System (K945028) and Oncology Salvage System (K002757).
Device Description: The Expandable Knee is an additional component to Biomet's Oncology Salvage System that qives the surgeon the ability to expand the prosthesis as a patient grows. All expansion takes place where the natural bone has been removed. The device does not "lengthen" existing bones.
The devices are available in two styles or expansion mechanisms: a clip-style and a screw-style. The clip-style is available as either a one-piece unit with an integrated distal femoral surface or as a diaphyseal segment for use with the distal femoral replacement component of Biomet's Oncology Salvage System constrained knee system. Clip-style devices are available in 7 initial replacement lengths of 13cm to 19cm providing an additional expansion from 3cm to 9cm. The screw-style expandable segment relies on movement of a screw for expansion. The device has an integrated distal femoral component. The screw-style Expandable Knee is available in 11 sizes providing a maxim
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
행
Warsaw. IN 46582
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL biomet@biomet.com
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381
page 2 of 2
expansion from 3cm to 13cm. A series of intramedually stems form 9mm to 19mm in diameter are available for cemented fixation of the remaining femoral bone. In addition to a set number of sizes, Biomet will offer customized components designed to more closely match patient anatomy. These components will be designed within a predefined envelope.
.All types of expandable components are intended for use with components of Biomet's Oncology Salvage System.
Intended Use: The Expandable Knee 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.
Summary of Technologies: The materials, surface finishes, and processing of the Expandable Knee are similar to the predicate devices.
Non-Clinical Testing: Mechanical analysis of both the screw-type and clip-type Expandable Knee has been conducted. Analysis showed that the strength of the expandable devices exceeds that of the clinically success predicate Finn® Knee device. Fatigue testing of the screw-type (worst-case) device has been conducted. This testing showed that the screw mechanism could successfully withstand anatomic loading conditions at maxim expansion. The testing also demonstrated that the expansion mechanism remained functional after fatigue.
Clinical Testing: None provided
All trademarks are property of Biomet, Inc.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 a stylized symbol that resembles a human figure or a caduceus, with three horizontal lines above it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 6 2002
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K020381
Trade/Device Name: Expandable Knee Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO Dated: January 30, 2002 Received: February 5, 2002
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 forth in the quality systems (OS) 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 – Ms. Patricia Sandborn Beres
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
R-Mark N. Milliman
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
KO20381 510(k) Number (if known):
Device Name: Expandable Knee
Indications For Use:
The Expandable Knee 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.
Mark N Milbers
Division of General, Restor rave and Neurological Devices
510(k) Number __
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
0000000