(52 days)
Not Found
No
The summary describes a mechanical knee implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
This device is a knee system intended to treat painful and disabled joints resulting from various medical conditions and injuries, which aligns with the purpose of a therapeutic device.
No
The provided text describes a knee implant system (AVL Hinge Knee System) used for joint replacement and correction of deformities or injuries. It lists indications for use that relate to conditions requiring surgical intervention, not diagnosis. There is no mention of the device being used to identify or characterize diseases or conditions.
No
The device description clearly states it is a physical knee implant system composed of hardware components (femoral component, tibial component, yoke, axle, polyethylene bearing).
No, 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, or tissue) to provide information about a person's health.
- Device Description: The AVL Hinge Knee System is a prosthetic implant designed to replace a damaged knee joint. It is a physical device implanted into the body.
- Intended Use: The intended uses listed are all related to treating conditions affecting the knee joint through surgical implantation of the device.
The information provided clearly describes a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The indications for use of the AVL Hinge Knee System are:
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, heumatic 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 for cemented use only.
Product codes
KRO
Device Description
The AVL Hinge Knee System is composed of a modular femoral component that is joined to a modular libia component by means of a yoke and an axle, A polychylene bearing modular tiblai component by means of a yorks and an alle the femoral component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint, femorotibial
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
Clinical and Non-Clinical Testing: None provided
Key Metrics
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
AUG 5 - 2005
K05/570, 1/1
BIOMET
510(k) Summary
Applicant/Sponsor: Biomet Manufacturing Corp.
Contact Person: Patricia Sandborn Beres Senior Regulatory Specialist
Proprietary Name: AVL Hinge Knee System
Common Name: Constrained Knee
Classification Name: Knee joint, femorotibial, metal/polymer, constrained, cemented prosthesis (21 CFR 888.3510)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The AVL Hinge Knee System is
ter System in Station Station States AVI, Hingo Koos System (K010774): Orth Legally Marketed Devices To Which Substantial Equit and Products AVL Hinge Knee System (K010774); Orthopedic Salvage
substantially equivalent to the following Biomet products System (OSS™) (K002757); Finn® Knee System (K945028).
Device Description: The AVL Hinge Knee System is composed of a modular femoral component that is joined to a Device Description: The AVL Hinge Khee System is culmpost of the between the femoral and tibial
modular libia component by means of a yoke and an axle, A polychylene bearing modular tiblai component by means of a yorks and an alle the femoral component.
Intended Use: The indications for use of the AVL Hinge Knee System are:
- ended Use: The indications for use of the AVC Hinge Knee Oystem are.
Painful and disabled joint resulting from avascular necrosis, osteoarthritis, heumatic 1. arthritis - Correction of varus, valgus or post traumatic deformity
-
- Correction of varus, valgus of post tradmatic deformly
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
- Correction of varus, valgus of post tradmatic deformly
-
- Ligament deficiencies 4.
- Tumor resections 5.
- Tumor resections
Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, ତ. unmanageable using other techniques - Revision of previously failed total joint arthroplasty 7.
- Trauma 8.
These devices are for cemented use only.
Summary of Technologies: The technological characteristics (materials, design, sizing and indications) of the AVL
and Characterial Child Marketin Hotlinette devices or other Summary of Technologies: The technological characteristics (matchae) (and of the may of the summity cleared devices.
Hinge Knee System are similar to or identical to the prev
Clinical and Non-Clinical Testing: None provided
All trademarks are property of Biomet, Inc.
| MAILING ADDRESS | P.O. Box 587
Warsaw, IN 46581-0587 |
|------------------|---------------------------------------|
| SHIPPING ADDRESS | 56 E. Bell Drive
Warsaw, IN 46582 |
| OFFICE | 574.267.6639 |
| FAX | 574.267.8137 |
| 151 | |
| E-MAIL | biomet@biomet.com |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is written around the circle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 5 - 2005
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corporation 56 East Bell Drive. P.O. Box 587 Warsaw, Indiana 46582
Re: K051570
Trade/Device Name: AVL Hinge Knee System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO Dated: June 13, 2005 Received: June 14, 2005
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 (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.
2
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), please contact the Office of Compliance at (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
s. Hype Rlvodn
N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): ___
Device Name: AVL Hinge Knee System
Indications For Use:The indications for use of the AVL Hinge Knee System are:
- form I or OSC. The Indications from avascular necrosis, osteoarthritis,
- rheumatoid arthritis or traumatic arthritis
-
- Correction of varus, valgus or post traumatic deformity
-
- Correction of raiges of Feets, raigue of Ecotomy, arthrodesis, or previous joint replacement
-
- Ligament deficiencies
-
- Tumor resections
-
- Turnor reseotions
- Treatment of non-unions, femoral neck and trochanteric fracture of the rreadmont of hon anions involvement, unmanageable using other techniques
-
- Revision of previously failed total joint arthroplasty
-
- Trauma
These devices are for cemented use only
These devices are for cemented use only
Prescription Use X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __
(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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
510(k) Number K059570