(30 days)
The intended use of the subject MRS Pediatic Tibial Bearing Components and the MRS Pediatric All Poly Tibial Components is identical to that of the Modular Replacement System. The Modular Replacement System was cleared via 510(k) #K952970. A second submission, reference 510(k) #K972401, was found substantially equivalent which expanded the indications for use for the system. The original indications for use were for oncology patients where radical resection of the distal femur/proximal tibia is required. The expanded indications for use are limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage procedure would include surgical intervention for severe trauma, failed previous knee arthroplasties, and/or oncology indications.
As with the predicate Kinematic II Rotating Hinge Knee Metal Tibial Bearing Component and the Kinematic II Rotating Hinge Knee Tibial Plugs, the subject MRS Pediatric Tibial Bearing Components and the MRS Pediatric All Poly Tibial Components are single use devices. They are intended for cemented fixation only. The subject MRS Pediatric Tibial Bearing Components and the MRS Pediatric All Poly Tibial Components are intended to be used in conjunction with the commercially available components of the Modular Replacement System and the Kinematic II Rotating Hinge Knee System.
This Kinematic II Rotating Hinge Knee XXX-Small Tibial Bearing Component, Kinematic II Rotating Hinge Knee XX-Small Tibial Plug and the Kinematic II Rotating Hinge Knee XXX-Small Tibial Plug are currently marketed devices that are being modified components, MRS Pediatric Tibial Bearing Component, MRS Pediatric All Poly Tibial Component PT2 (XX-Small) and the MRS Pediatric All Poly Tibial Component PT1 (XXX-Small) are substantially equivalent to features of the predicate devices, which have been cleared for marketing via the 510(k) process. The modifications address both design and material specification changes. The MRS Pediatric Tibial Bearing Component is manufactured from a cobalt-chromium alloy, which conforms to ASTM F-1537. The MRS Pediatric All Poly Tibial Components are manufactured from ultra-high molecular weight polyethylene, which conforms to ASTM F-648. The intended use of the subject MRS Pediatric Tibial Bearing Components and the MRS Pediatric All Poly Tibial Components are identical to that of the Modular Replacement System. These components are intended for cemented use only.
I am sorry, but based on the provided text, there is no information about explicit acceptance criteria or a study that evaluates the device's performance against such criteria. The document is a 510(k) premarket notification for a medical device (Kinematic II Rotating Hinge Knee) that has undergone modifications.
The document discusses:
- The proprietary and common names of the device.
- Its classification and regulatory class.
- The modifications made to certain components (changes in design and material specifications).
- The substantial equivalence to predicate devices.
- The materials used for the modified components (Cobalt-chromium alloy and ultra-high molecular weight polyethylene, conforming to ASTM standards).
- The intended use of the modified components, which is identical to the Modular Replacement System and the Kinematic II Rotating Hinge Knee System, and includes cemented use only.
- The indications for use, which were previously expanded to include limb salvage procedures for severe trauma, failed previous knee arthroplasties, and oncology indications.
- The device is a single-use device.
Crucially, the document does NOT contain:
- A table of acceptance criteria and reported device performance.
- Details about a study conducted to demonstrate the device meets any performance criteria (e.g., clinical trials, bench testing results, sensitivity, specificity, accuracy).
- Information on sample size, data provenance, expert consensus, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
This 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study against specific acceptance criteria. The modifications are primarily related to design and materials, and the justification for substantial equivalence relies on existing clearances and the intended use remaining the same.
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AUG 12 1999
Kinematic II Rotating Hinge Knee
Special 510(k) Premarket Notifica
Special 510(k) Summary - Device Modification Summary of Safety and Effectiveness for the Kinematic II Rotating Hinge Knee
| Proprietary Name: | Kinematic II Rotating Hinge Knee |
|---|---|
| Common Name: | Knee Prosthesis |
| Classification Name and Reference : | Knee joint, femorotibial, metal/polymer, semi-constrained, cemented prosthesis 21 CFR §888.3530 |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87 LGE |
| For Information contact: | Karen Ariemma, Regulatory Affairs SpecialistHowmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677(201) 760-8187Fax: (201) 934-4368 |
This Kinematic II Rotating Hinge Knee XXX-Small Tibial Bearing Component, Kinematic II Rotating Hinge Knee XX-Small Tibial Plug and the Kinematic II Rotating Hinge Knee XXX-Small Tibial Plug are currently marketed devices that are being modified components, MRS Pediatric Tibial Bearing Component, MRS Pediatric All Poly Tibial Component PT2 (XX-Small) and the MRS Pediatric All Poly Tibial Component PT1 (XXX-Small) are substantially equivalent to features of the predicate devices, which have been cleared for marketing via the 510(k) process. The modifications address both design and material specification changes. The MRS Pediatric Tibial Bearing Component is manufactured from a cobalt-chromium alloy, which conforms to ASTM F-1537. The MRS Pediatric All Poly Tibial Components are manufactured from ultra-high molecular weight polyethylene, which conforms to ASTM F-648. The intended use of the subject MRS Pediatric Tibial Bearing Components and the MRS Pediatric All Poly Tibial Components are identical to that of the Modular Replacement System. These components are intended for cemented use only.
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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 features the department's name around the perimeter. In the center is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1.2 1999
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics 59 Route 17 Allendale, New Jersey 07401
Re: K992346
Trade Name: Kinematic II Rotating Hinge Knee Regulatory Class: II Product Code: LGE and KRO Dated: July 9, 1999 Received: July 13, 1999
Dear Ms. Ariemma:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
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Page 2 - Ms. Karen Ariemma
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
- Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Page 1 of 1
510(k) Number (if known): K 993346
Device Name: Howmedica MRS Pediatric Tibial Bearing Component and MRS All Poly Tibial Component (modified Kinematic II Rotating Hinge Knee components)
The intended use of the subject MRS Pediatic Tibial Bearing Components and the MRS Pediatric All Poly Tibial Components is identical to that of the Modular Replacement System. The Modular Replacement System was cleared via 510(k) #K952970. A second submission, reference 510(k) #K972401, was found substantially equivalent which expanded the indications for use for the system. The original indications for use were for oncology patients where radical resection of the distal femur/proximal tibia is required. The expanded indications for use are limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage procedure would include surgical intervention for severe trauma, failed previous knee arthroplasties, and/or oncology indications.
As with the predicate Kinematic II Rotating Hinge Knee Metal Tibial Bearing Component and the Kinematic II Rotating Hinge Knee Tibial Plugs, the subject MRS Pediatric Tibial Bearing Components and the MRS Pediatric All Poly Tibial Components are single use devices. They are intended for cemented fixation only. The subject MRS Pediatric Tibial Bearing Components and the MRS Pediatric All Poly Tibial Components are intended to be used in conjunction with the commercially available components of the Modular Replacement System and the Kinematic II Rotating Hinge Knee System.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||||
|---|---|---|---|---|
| Prescription Use | Yes | OR | Over-The-Counter Use | No |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | |||
| (Division Sign-Off) | ||||
| Division of General Restorative Devices | ||||
| 510(k) Number | K992346 |
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.