(324 days)
The LINEAGE® HA Acetabular Shells are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The LINEAGE® HA Acetabular Shells are intended for single patie
A Hydroxylapatite (HA) coating is being added to the LINEAGE® Acetabular Shells previously cleared for market in the US.
The LINEAGE® HA Acetabular Shells are single use components, intended for use as part of an uncemented total hip arthroplasty system; in conjunction with WMT's poly or metal liners; and ceramic or metal femoral heads.
The provided text is a 510(k) Summary of Safety and Effectiveness for a medical device, the LINEAGE® HA Acetabular Shells. It describes the device, its intended use, and claims substantial equivalence to previously cleared devices. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary lists:
- Submitted By: Wright Medical Technology, Inc.
- Date: November 06, 2004
- Proprietary Name: LINEAGE® HA Acetabular Shells
- Common Name: Acetabular Shells
- Classification Name and Reference: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium-phosphate - Class II (21 CFR 888.3358); Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Class II (21 CFR 888.3330); Hip joint metal/metal semi-constrained, with an uncemented acetabular component prosthesis - Class III
- Device Product Code and Panel Code: Orthopedics/87/MEH/LPH/KWA
- Intended Use: Total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with specified conditions including non-inflammatory and inflammatory degenerative joint disease, correction of functional deformity, revision procedures, and treatment of nonunion/fractures of the proximal femur.
- Device Description: A Hydroxylapatite (HA) coating is added to previously cleared LINEAGE® Acetabular Shells.
- Substantial Equivalence Information: The device is claimed to be substantially equivalent to predicate devices previously cleared for market. Safety and effectiveness are "adequately supported by the substantial equivalent information, materials data, and testing results provided within this Premarket Notification."
The acceptance criteria and study details requested in the prompt are not present in the provided text. The document states that "testing results" were provided, but it does not elaborate on what those tests were, their acceptance criteria, or their outcomes. The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with specific performance metrics and acceptance criteria as might be found in a PMA.
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SEP 2 9 2005
Image /page/0/Picture/1 description: The image shows the word "WRIGHT" in large, bold letters at the top. Below the word, there is a graphic design. Underneath the graphic design, the text "K043099" is written in cursive. The text "Page 1 of 2" is written in cursive on the right side of the image. The words "MARY" and "FECTIVENESS" are written on the left side of the image.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the LINEAGE® HA Acetabular Shell.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | November 06, 2004 |
| Contact Person: | Jeanine H. ReddenRegulatory Affairs Specialist II |
| Proprietary Name: | LINEAGE® HA Acetabular Shells |
| Common Name: | Acetabular Shells |
| Classification Name and Reference: | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate- Class II21 CFR 888.3358 Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented- Class II21 CFR 888.3330 Hip joint metal/ metal semi-constrained, with an uncemented acetabular component prosthesis - Class III |
| Device Product Code and Panel Code: | Orthopedics/87/MEH/LPH/KWA |
DEVICE INFORMATION
A. INTENDED USE
The LINEAGE® HA Acetabular Shells are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
-
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
-
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed 4.
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur 5. with head involvement that are unmanageable using other techniques.
headquarters
Wright Medical Technology, Inc. 5677 Airline Road Arlington. TN 38002 901.867.9971 phone
international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy
905.826.1600 Canada 011.81.3.3538.0474 Japan 011-33-1-45.13.24.40 France 011.44.1483.721.404 UK
011.49.4161.745130 Germany
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Page 24
The LINEAGE® HA Acetabular Shells are single use components, intended for use as part of an uncemented total hip arthroplasty system; in conjunction with WMT's poly or metal liners; and ceramic or metal femoral heads.
B. DEVICE DESCRIPTION
A Hydroxylapatite (HA) coating is being added to the LINEAGE® Acetabular Shells previously cleared for market in the US.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The LINEAGEE® HA Acetabular Shells are substantially cquivalent to the predicate devices previously cleared for market. The safety and effectiveness of the LINEAGLI:® HA Acetabular Shells is adequately supported by the substantial equivalent information, materials data, and testing results provided within this Premarket Notification.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines, next to a circular seal. The seal contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter of the circle.
SEP 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jeanine H. Redden Senior Regulatory Affairs Specialist Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K043099
Trade/Device Name: LINEAGE® HA Acetabular Shells Regulation Numbers: 21 CFR 888.3330 Regulation Names: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Codes: KWA, LPH, MEH Dated: August 15, 2005 Received: August 26, 2005
Dear Ms. Redden:
We have reviewed your Scction 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 complics 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Ms. Jeanine H. Redden
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/dsma/dsmamain.html
Sincerely yours,
sincerely yours,
Mark A. Milliken
Mark Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word, there are three stylized, horizontal lines that appear to be converging towards the right. The lines are thick and black, contrasting with the white background. The letters are all capitalized and evenly spaced.
Indications for Use Indications for USE Ko430999
Device Name: LINEAGE® HA Acetabular Shells
Indications For Use:
The LINEAGE® HA Acetabular Shells are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
-
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformity; and, 3.
-
- revision procedures where other treatments or devices have failed
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with 5. head involvement that are unmanageable using other techniques.
The LINEAGE® HA Acetabular Shells are intended for single patie
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K04307
Prescription Use (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)
Page 1 of /
headquarters Wright Medical Technology, Inc.
Arlinaton. TN 38002 5677 Airline Road
901.867.9971 phone
international subsidiaries 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy
011.81.3.3538.0474 Japa
011.33.1.45.13.24.40 Fran 011.44.1483.721.404 UK
011.49.4161.745130 Germany
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip 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 and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.