(28 days)
Not Found
Not Found
No
The document describes a mechanical hip prosthesis and does not mention any AI or ML components or functions.
Yes
The device is a prosthesis intended to replace a hip joint in patients with hip dislocation, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is described as a "cemented prosthesis intended to replace a hip joint," which indicates it is a therapeutic device used for treatment, not for diagnosis.
No
The device description clearly indicates it is a physical prosthesis (liner) intended to replace a hip joint, not a software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "cemented prosthesis intended to replace a hip joint." This describes a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description further elaborates on its use with existing hip components and its function as a replacement for a hip joint.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests outside the body on biological samples. This device is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
The Retlection Constrained Liner construct is a cemented prosthesis intended to replace a hip joint. The Reflection Constrained Liner is intended for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-operative instability and for whom all othe · options to constrained acetabular components have been considered.
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-operative 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.
Product codes
KWZ
Device Description
The Re lection 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 (22, 26, 28, and 32 mm) and Relection 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 22, 26, 28, or 32 mm metal femoral head is used with the femoral component. Ceramic heads or skirted femoral heads of any naterial should not be used with the Reflection Constrained Liner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and effectiveness of this device are adequately supported by the substantial equiv lence information, materials data, and testing results provided within this Special Premarket Notification. Such infornation 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, 21/02 and Guidance Document for Data Requirements For Ura-high Polyethylene (UHMWPE) Used In Bearing Surfaces For Orthopedic Devices, dated September 7, 1997 and Guidance Document for Testing Acetc bular Cup Prosthesis (dated May 1, 1995).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reflection Constrained Liner (28 mm), Reflection Acetalular Component, Johnson & Johnson S-Rom Poly-Dial Constrained Liner, Osteonics Constrained Acetalvular Insert, Zimmer Triology Acetabular System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
NOV 2 6 2003
K 033 442 pge141
510(K) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS Reflection Constrained Liner
| Submitted By | Smith & Nephew, Inc.
Orthopaedic Division
1450 Brooks Road
Memphis, TN 38116 |
|-------------------------------------|-------------------------------------------------------------------------------------------------|
| Date: | October 28, 2003 |
| Contact Person: | Kanu Vadodaria - Sr. Regulatory/Clinical Affairs Specialist |
| Proprietary Name: | Reflection Constrained Liner |
| Common Name: | Constrained Liner |
| Classification Name and Reference: | 888.33 10 - Hip Joint Metal/Polymer Constrained
Cemented or Uncemented Prosthesis - Class II |
| Device Product Code and Panel Code: | Orthopedics/87/KWZ |
A. INTENDED USE
The Retlection Constrained Liner construct is a cemented prosthesis intended to replace a hip joint. The Reflection Constrained Liner is intended for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-operative instability and for whom all othe · options to constrained acetabular components have been considered.
B. DEVICE DESCRIPTION
The Re lection 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 (22, 26, 28, and 32 mm) and Relection 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 22, 26, 28, or 32 mm metal femoral head is used with the femoral component. Ceramic heads or skirted femoral heads of any naterial should not be used with the Reflection Constrained Liner.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The R . flection Constrained Liner is similar to the following: A) Reflection Constrained Liner (28 mm) B) Reflection Acetal ular Component C) Johnson & Johnson S-Rom Poly-Dial Constrained Liner D) Osteonics Constrained Acetalvular Insert and E) 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 equiv lence information, materials data, and testing results provided within this Special Premarket Notification. Such infornation 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, 21/02 and Guidance Document for Data Requirements For Ura-high Polyethylene (UHMWPE) Used In Bearing Surfaces For Orthopedic Devices, dated September 7, 1997 and Guidance Document for Testing Acetc bular Cup Prosthesis (dated May 1, 1995).
1
Image /page/1/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 image of an eagle or bird with three horizontal lines above it, representing the department's mission to protect the health of all Americans and provide essential human services.
NOV 2 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kanu Vadodaria Senior Regulatory/Clinical Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis. Tennessee 38116
Re: K033442
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: II Product Code: KWZ Dated: October 28, 2003 Received: October 29, 2003
Dear Mr. Vadodaria:
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 - Mr. Kanu Vadodaria
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) 594-4639. 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 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,
Mark A. Milkeison
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
Indications for Use Statement Reflection Constrained Liner
5 | 0(k) Number (if known): K0}344L
I evice 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 intra-operative 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.
(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 No
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K033442