(35 days)
Not Found
No
The summary describes a mechanical knee implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for total knee arthroplasty surgery to reduce pain and improve knee function in patients with various degenerative joint diseases. This directly aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device is a knee implant system designed for surgical replacement in total knee arthroplasty, not for diagnosing conditions.
No
The device description explicitly states it is composed of physical components (Femoral component, Tibial component, Patella components) made of materials like CoCr and polyethylene, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Medial Rotation Knee™ System is a total knee arthroplasty system. It is a physical implant designed to replace damaged knee joints.
- Intended Use: The intended use clearly states it is for cemented implantation for use in total knee arthroplasty surgery. This is a surgical procedure performed directly on the patient's body, not an examination of a specimen outside the body.
The information provided describes a surgical implant, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Medial Rotation Knee™ System is intended for single-use 'cemented' imajor and lea The Medial Notation Rhoo - Oyecty surgery for the reduction or relief of pain and/or ior use in a total And artin opides) - still of patients with the following conditions:
- Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic arthritis, or – avascular necrosis;
- Inflammatory degenerative joint disease including rheumatoid arthritis;
- Correction of varus, valgus, or post traumatic deformity;
- Correction or revision of unsuccessful osteotomy or arthrodesis;
- Revision procedures where other treatments or devices have failed;
- Treatment of fractures that are unmanageable using other techniques;
Product codes
87JWH
Device Description
The Medial Rotation Knee™ System is both a primary and revision total knee system composed of a CoCr Femoral component mating with a stemmed CoCr metal backed polyethylene Tibial and all-poly Patella components. The conguency in tibialfemoral and patellafemoral articulation allow for natural knee movement and ROM while minimizing polyethelene wear.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
skeletally mature patients
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K830726, K853730, K943025, K972770, K991052
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Finsbury (Instruments) Limited 510(k) for the Medial Rotation Knee January 19, 2002
ge lof
Section C: Summary of Safety & Effectiveness
510(k) Summary of Safety and Effectiveness
SAFE MEDICAL DEVICES ACT OF 1990
SAFE MEDICAL DEVICES ACT OF 1990
| NAME OF FIRM: | Finsbury (Instruments) Limited
13 Mole Business Park
Randalls Road
Leatherhead, Surrey KT22 OBA
United Kingdom |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| 510(k) FIRM CONTACT: | Al Lippincott
Engineering Consulting Services, Inc.
3150 E. 200th St.
Prior Lake, MN 55372 |
| TRADE NAME: | Medial Rotation Knee™ System |
| COMMON NAME: | Knee Prosthesis |
| CLASSIFICATION: | Prosthesis, Knee patellofemorotibial, Semi-constrained, Cemented, Polymer/Metal/Polymer per 21CFR, Sec 888.3390 |
| DEVICE PRODUCT CODE: | 87JWH |
| SUBSTANTIALLY
EQUIVALENT: | DePuy, Freeman/Samuelson Total Knee (K830726)
Sulzermedica, Mark II Freeman/Samuelson Total Knee System (K853730)
Biomet, Freeman/Samuleson Total Knee System (K943025)
Wright Medical Technology, Inc., Advance Ultra-Conguent Tibial Insert (K972770)
Renaissance Instruments, LLC., FS 1000 Knee System (K991052) |
| DEVICE DESCRIPTION: | The Medial Rotation Knee™ System is both a primary and revision total knee system composed of a CoCr Femoral component mating with a stemmed CoCr metal backed polyethylene Tibial and all-poly Patella components. The conguency in tibialfemoral and patellafemoral articulation allow for natural knee movement and ROM while minimizing polyethelene wear. |
| INTENDED USE: | The Medial Rotation Knee™ System is intended for single-use cemented implantation for use in total knee arthroplasty surgery for the reduction in relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
• Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic arthritis, or avascular necrosis
• Inflammatory degenerative joint disease including rheumatoid arthritis
• Correction of varus, valgus, or post traumatic deformity
• Correction or revision of unsuccessful osteotomy or arthrodesis
• Revision procedures where other treatments or devices have failed
• Treatment of fractures that are unmanageable using other techniques |
| BASIS OF SUBSTANTIAL
EQUIVALENCY: | The Medial Rotation Knee™ System is substantially equivalent to the many semi- constrained metal/polyethylene total knee systems currently on the market and specifically to the:
(1). FS 1000 Knee System from Renaissance Instruments, LLC.,
(2). Advance Ultra-Congruent Tibial Insert from Wright Medical Technology, Inc, and
(3). Freeman/Samuelson Total Knee System from Biomet, Inc. |
| SUMMARY OF SAFETY
AND EFFECTIVENESS: | The Medial Rotation Knee™ System is shown to be safe and effective with over 30 years of proven clinical use. |
FEB 2 6 2002
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2002
Finsbury (Instruments) Limited c/o Mr. Al Lippincott U.S. Regulatory Representative Engineering Consulting Services, Inc 3150 E. 200m St Prior Lake, Minnesota 55372
Re: K020214
Trade Name: Medial Rotation Knee System Regulation Number: 888.3390 Regulation Name: Knee patellofemorotbibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: January 19, 2002 Received: January 22, 2002
Dear Mr. Lippincott:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreate) to togally to togally with Medical Device Amendments, or to conimered proc to Hay 20, 2017, 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 I ho general ocharels proving 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 If your device is olassinod (500 a00 v) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation of t 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 r lease be advisou that I Drivision that your device complies with other requirements of the Act that I Dri has made a sold regulations administered by other Federal agencies. You must or any I ederal statutes and registements, including, but not limited to: registration and listing (21 compy with an all the 110 0 1 quirt 801); good manufacturing practice requirements as set Of K Part 6077, abouting (21 CFR Part 820); and if applicable, the electronic form in the quality of realist (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Al Lippincott
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manketing your as warence of your device to a legally premarket notification. The PDA midning of backannal open 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 II you desire specific advice to: your worth devices), please contact the Office of additionally 21 CFR Fall 809.10 for in Viato Charlestions on the promotion and advertising of Compliance at (301) 594-4637. Tidataonally, Nance at (301) 594-4639. Also, please note the your device, picase comate and Other of exerce to premarket notification™ (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general information on your responsional 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,
K. Mark M. 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
3
Image /page/3/Picture/0 description: The image shows the logo for Finsbury Instruments. The logo consists of a stylized letter "F" inside of a circle. Below the circle are the words "FINSBURY" in a larger font and "INSTRUMENTS" in a smaller font.
page lot
510(k) NUMBER:
Ko20214.
DEVICE NAME: Medial Rotation Knee™ System
INDICATIONS FOR USE:
The Medial Rotation Knee™ System is intended for single-use 'cemented' imajor and lea The Medial Notation Rhoo - Oyecty surgery for the reduction or relief of pain and/or ior use in a total And artin opides) - still of patients with the following conditions:
- Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic arthritis, or � avascular necrosis;
- Inflammatory degenerative joint disease including rheumatoid arthritis; �
- Correction of varus, valgus, or post traumatic deformity; �
- Correction or revision of unsuccessful osteotomy or arthrodesis; �
- Revision procedures where other treatments or devices have failed; �
- Treatment of fractures that are unmanageable using other techniques; �
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Wilkinson
(Division Sign-Off)
Division of Gener
of Gene
uro!
5100
Prescription Use
OR
Over-The-Counter-Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
H:\SUPPLIERS\Mr. Al Lippincott USA\Indications for Use 131201VP.doc
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