(131 days)
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Not Found
No
The document describes a passive implant (poly liner) and its mechanical properties, with no mention of AI/ML in the device description, intended use, or performance studies.
Yes
The device is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function, which are therapeutic outcomes.
No
This device is a prosthetic implant (poly liner) used in total hip arthroplasty, not a diagnostic tool. Its purpose is to replace part of a joint to reduce pain and improve function.
No
The device description clearly indicates it is a physical implant made of Ultra High Molecular Weight Polyethylene (UHMWPE) and includes details about its design features and wear testing. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for total hip arthroplasty to treat conditions affecting the hip joint. This is a surgical procedure involving the implantation of a medical device into the body.
- Device Description: The device is a physical implant made of Ultra High Molecular Weight Polyethylene (UHMWPE) designed to be part of a hip replacement system.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections.
The LINEAGE® A-CLASS™ Poly Liner is a surgically implanted medical device, not a diagnostic test performed on bodily samples.
N/A
Intended Use / Indications for Use
The LINEAGE® A-CLASS™ Poly Liner is 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; 2.
-
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed 4.
Product codes (comma separated list FDA assigned to the subject device)
LPH, JDI, LZO
Device Description
The design features of the LINEAGE® A-CLASS™ Poly Liner are summarized below:
- Ultra High Molecular Weight Polyethylene (UHMWPE) .
- Oura High Morecular Wolferal lip assembly to lock the liner into the actabular . shell
- Offered with 0° and 15° overhangs .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Hip joint
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The test device was the LINEAGE® A-CLASS™ Poly Liner and the control device was the LINEAGE® Poly Liner. Both the test and control devices were 28 mm inner diameter acetabular liners. The articulating surfaces of both the test and control device have the same finish. The hip simulators used were orbital bearing hip wear test machines manufactured by Shore Western Manufacturing, Inc. Both the test and control devices were tested for 5 million cycles. The material of the device was Ultra High Molecular Weight Polyethylene. The lubricant used was 90% alpha calf serum with 0.2% sodium azide, 20mM EDTA and distilled water. Both the test and control devices were sterilized.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Wear Test Information: The LINEAGE® A-CLASS™ Poly Liner exhibits 94% less wear than traditional LINEAGE® Liners. The average amount of wear at 5 million cycles for the test device was 424.7 mg less than that of the control device. The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The average amount of wear at 5 million cycles for the test device was 424.7 mg less than that of the control device.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
DEC 5 2005
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe m accordance with the 2 oct and in conformance with 21 CRF 807, this information serves as a Moural Devices for of Safety and Effectiveness for the LINEAGE® A-CLASS™ Poly Liner.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | October 5, 2005 |
| Contact Person: | Theresa Leister |
| Regulatory Affairs Specialist | |
| Proprietary Name: | LINEAGE® A-CLASS™ Poly Liner |
| Common Name: | Poly Acetabular Component |
| Classification Name and Reference: | 21 CFR 888.3350 Hip joint metal/polymer, semi- |
| constrained, cemented prosthesis - Class II | |
| 21 CFR 888.3358 Prosthesis, Hip, Semi- | |
| Constrained, metal/polymer, Uncemented -- Class II | |
| 21 CFR 888.3353 Prosthesis, hip, semi-constrained, | |
| metal/ceramic/polymer, cemented or non-porous, | |
| uncemented-- Class II | |
| Device Product Code and Panel Code: | Orthopedics/87/ IDI LZO LPH |
DEVICE INFORMATION
A. INTENDED USE
The LINEAGE® A-CLASS™ Poly Liner is 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; 2.
-
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed 4.
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
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Page 24
B. DEVICE DESCRIPTION
The design features of the LINEAGE® A-CLASS™ Poly Liner are summarized below:
- Ultra High Molecular Weight Polyethylene (UHMWPE) .
- Oura High Morecular Wolferal lip assembly to lock the liner into the actabular . shell
- Offered with 0° and 15° overhangs .
Wear Claim
The following marketing claim will be made for the LINEAGE® A-CLASS™ Poly Liner:
- The LINEAGE® A-CLASS™ Poly Liner exhibits 94% less wear than traditional . LINEAGE® Liners.*
*Wear Test Information
- (a) The LINEAGE® A-CLASS™ Poly Liner and the LINEAGE® Poly Lincr arc manufactured by Wright Medical Technology, Inc.
- (b) The test device was the LINEAGE® A-CLASS™ Poly Liner and the control device was the LINEAGE® Poly Liner
- (c) Both the test and control devices were 28 mm inner diameter acetabular liners.
- (d) The articulating surfaces of both the test and control device have the same finish.
- (e) The hip simulators used were orbital bearing hip wear test machines manufactured by Shore Western Manufacturing, Inc.
- (f) Both the test and control devices were tested for 5 million cycles.
- (g) The material of the device was Ultra High Molecular Weight Polyethylene.
- (h) The lubricant used was 90% alpha calf serum with 0.2% sodium azide, 20mM EDTA and distilled water.
- (i) The average amount of wear at 5 million cycles for the test device was 424.7 mg less than that of the control device.
- (j) Both the test and control devices were sterilized.
- (k) The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The indications for use and design features of the LINEAGE® A-CLASS™ Poly Liner are identical to the indications for use of the currently marketed LINEAGE® poly liner. The material used to manufacture the LINEAGE® A-CLASS™ Poly Liner is substantially equivalent to that which is used to manufacture the currently marketed LINEAGE® poly liner. The fundamental scientific technology of the modified device has not changed relative to the predicate device. The safety and effectiveness of the LINEAGE® A-Class Poly Liner are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
2
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 representation of a human figure with three overlapping profiles, symbolizing health and human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2005 DEC 2
Theresa Leister Regulatory Affairs Specialist Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K052026/S1
Trade/Device Name: LINEAGE® A-CLASS™ Poly Liner Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, JDI, LZO Dated: October 6, 2005 Received: October 7, 2005
Dear Ms. Leister:
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.
3
Page 2- Theresa Leister
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter wrif anow you to ough mating of substantial equivalence of your device to a legally prematics notinoadon: "The Presults 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 If you desire spocitie as not 12. J at (240) 276-0120. Also, please note the regulation entitled, Connact the Ories of Coursemarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mornational 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/industry/support/index.html.
Sincerely yours,
s M. N. M
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K052026
Device Name:_LINEAGE® A-CLASS™ Poly Liner
Indications For Use:
Indications For Use:
The LINEAGE® A-CLASS™ Poly Liner is indicated for use in total hip arthroplasty with The LINEAGE® A-CLASS™ Poly Liner is indicated for use in comments
reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis,
- non-inflammatory de decided in a basinfid his dysplasi nori-inflantinatory "degential on" painful hip dysplasia;
ankylosis, protrusio acetabuli, and painful as rhoumet
- ankylosis, protrusio accadoni, and paint disease such as rheumatoid arthritis;
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- inflammatory degene
-
- Innummitatory functional deformity; and,
-
- correction of fullchonal deformly, and,
- revision procedures where other treatments or devices have failed
Prescription Use X (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)
Sim Off
ion Sign-Division of General. Restorative, and Neurological Druses
Page 1 of 1___
510(k) Number K052026
I