(199 days)
The Reflection Constrained Liner is a cemented or uncemented prosthesis intended to replace a hip joint. The Reflection Constrained Liner is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-perative instability and for whom all other options to constrained acetabular components have been considered.
The components subject of this notification are to be used with the Reflection Acetabular System, which is indicated for use with or without cement, and includes single use devices.
The Reflection Constrained Liner is used with existing appropriately sized Reflection Acetabular Shells. The Reflection Constrained Liner can be used with previously implanted femoral components, femoral heads (28 mm only) and Reflection Acetabular Shells such as in a revision case, or it may be used in primary cases and implanted along with the shell, head and stem. Any appropriately sized Reflection Shell may be utilized. Any stem may be used, provided a 28 mm metal femoral heads is used with the femoral component. Ceramic heads or skirted femoral heads of any material should not be used with the Reflection Constrained Liner.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Reflection Constrained Liner) and an FDA clearance letter. These documents attest to the device's substantial equivalence to predicate devices but do not include details about specific performance acceptance criteria or a study designed to demonstrate compliance with such criteria. The document mentions "materials data, and testing results provided within this Abbreviated Notification" to support safety and effectiveness, and refers to several guidance documents, but the specifics of these tests and their results are not detailed in the provided excerpts.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the given text.
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KOZ1803 510(K) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS Reflection Constrained Liner
| Submitted By: | Smith & Nephew, Inc.Orthopaedic Division1450 Brooks RoadMemphis, TN 38116 |
|---|---|
| Date: | DEC 1 9 2002May 31, 2002 |
| Contact Person: | Janet Johnson Akil- Director, Regulatory Affairs |
| Proprietary Name: | Reflection Constrained Liner |
| Common Name: | Constrained Liner |
| Classification Name and Reference: | 888:33 10 - Hip Joint Metal/Polymer ConstrainedCemented or Uncemented Prosthesis - Class II |
| Device Product Code and Panel Code: | Orthopedics/87/KWZ |
A. INTENDED USE
The Reflection Constrained Liner is a cemented or uncemented prosthesis intended to replace a hip joint. The Reflection Constrained Liner is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-perative instability and for whom all other options to constrained acetabular components have been considered.
B. DEVICE DESCRIPTION
The Reflection Constrained Liner is used with existing appropriately sized Reflection Acetabular Shells. The Reflection Constrained Liner can be used with previously implanted femoral components, femoral heads (28 mm only) and Reflection Acetabular Shells such as in a revision case, or it may be used in primary cases and implanted along with the shell, head and stem. Any appropriately sized Reflection Shell may be utilized. Any stem may be used, provided a 28 mm metal femoral heads is used with the femoral component. Ceramic heads or skirted femoral heads of any material should not be used with the Reflection Constrained Liner.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The Reflection Constrained Liner is similar to the following: A) Reflection Acetabular Component B) Johnson & Johnson S-Rom Poly-Dial Constrained Liner C) Osteonics Constrained Acetabular Insect and D) Zimmer Triology Acetabular System.
D. SUMMARY OF TECHNOLOGICAL COMPARISON
The intended use, material, type of interface and design features of the Reflection Constrained Liner are similar to their predicate counterparts. The safety and effectiveness of this device are adequately supported by the substantial equivalence information, materials data, and testing results provided within this Abbreviated Notification. Such information was generated per data requirements outlined in the Class II Special Controls Guidance Document: Hip Joint Metal Polymer Constrained and Uncemented Prosthesis; Guidance for Industry and FDA dated April 30, 2002 and Guidance Documents For Utra-high Molecular Weight Polyethylene (UHMWPE) Used In Bearing Surfaces For Orthopedic Devices, dated September 7, 1997 and Guidance Document for Testing Acetabular Cup Prosthesis (dated May 1, 1995)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2002
Ms. Janet Johnson Akil Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116
Re: K021803
Trade/Device Name: Reflection Constrained Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWZ Dated: September 18, 2002 Received: September 20, 2002
Dear Ms. Akil:
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.
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Page 2 -- Ms. Janet Johnson Akil
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 (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.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
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
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510(k) Number K021803
Device Name: Reflection Constrained Liner
Indications for Use:
:
- The Reflection Constrained Liner is a cemented or uncemented prosthesis intended to replace a hip joint. The Reflection Constrained Liner is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intraoperative instability and for whom all other options to constrained acetabular components have been considered.
The components subject of this notification are to be used with the Reflection Acetabular System, which is indicated for use with or without cement, and includes single use devices.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use
OR Over-The Counter Use __________ (Per 21 CFR 801.109)
Miriam C. Provost
ivision of General, Restorative and Neurological Devices
19(k) Number K0 21803
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”