(21 days)
The PROFEMUR® LX Hip Stem 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;
- correction of functional deformity; and,
- revision procedures where other treatments or devices have failed
The design features of the PROFEMUR® LX Hip Stem are summarized below:
- Manufactured from titanium alloy (Ti6A14V) .
- Offered in one medial flare option .
- Tri-planar proximal geometry with plasma sprayed surface .
- Cylindrical, splined, and slotted distal stem with glassbead surface .
- Threaded hole with slot impaction mechanism .
- Polished distal tip and collar .
- Table of Acceptance Criteria and Reported Device Performance:
| Feature/Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence | The PROFEMUR® LX Hip Stem is "substantially equivalent" to predicate devices. |
| Indications for Use | Identical to predicate devices. |
| Design Features | Substantially equivalent to predicate devices. |
| Fundamental Scientific Technology | Unchanged relative to predicate devices. |
| Safety and Effectiveness | Adequately supported by substantial equivalence information, materials information, and analysis data. |
Note: This 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining and meeting specific, quantitative acceptance criteria for a novel device.
-
Sample Size for Test Set and Data Provenance:
- Sample Size: Not applicable. The submission does not describe a clinical study with a "test set" in the traditional sense for evaluating device performance against pre-defined metrics. Instead, it relies on demonstrating substantial equivalence to existing, legally marketed devices.
- Data Provenance: Not applicable. The submission does not refer to data from a clinical trial or observational study for a test set.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. No "ground truth" was established for a test set as there was no independent evaluation of the device's clinical performance in the manner of a new device requiring such a study. The evaluation focused on equivalence to predicate devices already on the market.
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Adjudication Method for the Test Set:
- Not applicable. No test set requiring adjudication was described.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is not mentioned or implied in the provided document. The submission is for a hip stem, a medical implant, and does not involve AI or image reading.
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Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- Not applicable. This device is a hip stem and does not involve an algorithm or AI.
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Type of Ground Truth Used:
- Not applicable in the context of a new device performance study. The "ground truth" for the submission is the established safety and effectiveness of the predicate devices based on their prior regulatory clearance.
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Sample Size for the Training Set:
- Not applicable. There is no mention of a "training set" as this is not an AI/algorithm-based device.
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How the Ground Truth for the Training Set was Established:
- Not applicable. There is no mention of a "training set" or corresponding ground truth establishment.
Study Proving the Device Meets Acceptance Criteria:
The "study" that proves the PROFEMUR® LX Hip Stem meets its "acceptance criteria" is the Premarket Notification (510(k)) process itself, which demonstrates Substantial Equivalence to legally marketed predicate devices.
The key aspects of this "study" are:
- Comparison to Predicate Devices: The submission explicitly states:
- "The indications for use of the PROFEMUR® LX Hip Stem are identical to the predicate devices."
- "The design features of the PROFEMUR® LX Hip Stem are substantially equivalent to those of the predicate devices."
- "The fundamental scientific technology of the modified device has not changed relative to the predicate devices."
- Supporting Information: "The safety and effectiveness of the PROFEMUR® LX Hip Stem are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." While the specific "materials information and analysis data" are not detailed in this summary, they would typically include engineering analyses, material testing, mechanical testing (e.g., fatigue strength, static strength), and biocompatibility assessments to show that the new device performs as safely and effectively as the predicate devices.
- FDA Review: The FDA's letter (K053588) confirms that "[We] have determined the devices are substantially equivalent... to legally marketed predicate devices."
Therefore, the "study" is a regulatory review of comparative data and evidence demonstrating that the PROFEMUR® LX Hip Stem is as safe and effective as predicate devices already on the market, rather than a clinical trial or performance study against pre-defined quantitative metrics for a novel technology.
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JAN 1 3 2006 1 of 2 Ko53588 ( Ca
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 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the PROFEMUR® LX Hip Stem.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | January 11, 2006 |
| Contact Person: | Theresa Leister |
| Regulatory Affairs Specialist II | |
| Proprietary Name: | PROFEMUR® LX Hip Stem |
| Common Name: | Hip Stem |
| Classification Name and Reference: | 21 CFR 888.3320 Hip joint metal/ metal semi-constrained, with a cemented acetabular component prosthesis - Class III |
| 21 CFR 888.3330 Hip joint metal/ metal semi-constrained, with an uncemented acetabular component prosthesis - Class III | |
| 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/ LZO, JDL, KWA |
DEVICE INFORMATION
A. INTENDED USE
The PROFEMUR® LX Hip Stem 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, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- correction of functional deformity; and, 3.
- revision procedures where other treatments or devices have failed 4.
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K053588 (pg 2 of 2)
B. DEVICE DESCRIPTION
The design features of the PROFEMUR® LX Hip Stem are summarized below:
- Manufactured from titanium alloy (Ti6A14V) .
- Offered in one medial flare option .
- Tri-planar proximal geometry with plasma sprayed surface .
- Cylindrical, splined, and slotted distal stem with glassbead surface .
- Threaded hole with slot impaction mechanism .
- Polished distal tip and collar .
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The indications for use of the PROFEMUR® LX Hip Stem are identical to the predicate devices. The design features of the PROFEMUR® LX Hip Stem are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the PROFEMUR® LX Hip Stem are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around it. Inside the circle is a symbol that resembles a stylized caduceus, which is a traditional symbol of medicine.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2006
Theresa Leister Regulatory Affairs Specialist II Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K053588 Trade/Device Name: PROFEMUR® LX Hip Stem Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component prosthesis Regulatory Class: III Product Code: KWA, LZO, JDL Dated: December 22, 2005 Received: December 23, 2005
Dear Ms. Leister:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 cither class II (Special Controls) or class III (PMA), they 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 devices comply with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
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Page 2 - Ms. Leister
comply with all the Act's requirements, including, but not limited to: registration and listing (21 Comply will an the Not 800 (2008) Part 801); good manufacturing practice requirements as set CFR Part 807); mooning (Dr CFR Part 820); and if applicable, the electronic forth in the quality byotens (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you're ough finding of substantial equivalence of your device to a legally premits to the are 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 If you desire specific ac arroliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on 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.
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Sincerely yours,
2
Mark N. 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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cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 Division D.O. f/t:ELF:rrr: 1/12/06
. -- . . .
:
. . .
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KOS3588
Indications for Use
510(k) Number (if known):
Device Name: PROFEMUR® LX Hip Stem
Indications For Use:
indications For Ose.
The PROFEMUR® LX Hip Stem is indicated for use in total hip arthroplasty for THE TROFEMOR® DA REP START Proved hip function in skeletally mature patients with the following conditions:
- I 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, 3.
-
- 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 ( )
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of General. Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K053588
1
§ 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.