(63 days)
The PROFEMUR® Z Titanium Plasma Sprayed 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 PROFEMUR® Z Titanium Plasma Sprayed Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.
The modular PROFEMUR® Z Titanium Plasma Sprayed hip stem is an uncemented distal femoral implant designed to couple with Wright Medical Technology's PROFEMUR® CoCr modular necks. The stem design was developed from the previously marketed PROFEMUR® Z Hip Stem ('STEM' K021346) and features the identical modular neck taper socket and is made of the identical Titanium alloy (ASTM F620) as previous hip stem designs by Wright. The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem features the identical substrate cross-sectional geometry as the PROFEMUR® Z Hip Stem (K0213146) with the addition of titanium plasma spray coating conforming to ASTM F1580 applied according to WMT specifications which covers the proximal 1/3 of the stem.
The provided text describes the PROFEMUR® Z Titanium Plasma Sprayed Hip Stem. As a Class III medical device, its clearance is primarily based on demonstrating substantial equivalence to predicate devices rather than meeting specific performance acceptance criteria through clinical or advanced non-clinical studies. The information available focuses on the device's design, materials, and manufacturing being identical or highly similar to previously cleared devices.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets those (or is substantially equivalent):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicitly based on Predicate Equivalence) | Reported Device Performance / Evidence |
|---|---|
| Material Composition | Identical Titanium alloy (ASTM F620) as previous hip stem designs by Wright. |
| Substrate Cross-Sectional Geometry | Identical to the PROFEMUR® Z Hip Stem (K0213146). |
| Modular Neck Taper Socket | Identical to previous hip stem designs by Wright. |
| Titanium Plasma Spray Coating (Proximal 1/3) | Conforms to ASTM F1580, applied according to WMT specifications. Identical to the plasma spray coating used on the PRO-FEMUR Hip System (K012091). Verified by testing within a vendor Master File. |
| Surface Finish (Non-coated portions) | Identical to the PROFEMUR® Z Hip Stem ('STEM Hip Replacement System' K021346). |
| Fatigue Performance (Distal & Proximal) | Evaluated according to ISO 7206-4, 6, and 8. (Specific "acceptance criteria" for these tests are not provided, but the statement implies successful completion to demonstrate equivalence/safety.) |
| Fretting Corrosion | Evaluated according to ASTM F1875. (Specific "acceptance criteria" are not provided, but the statement implies successful completion.) |
| Axial Disassembly Force | Evaluated according to ASTM F2009. (Specific "acceptance criteria" are not provided, but the statement implies successful completion.) |
| Intended Use & Indications for Use | Identical to existing Wright PROFEMUR® hip stems and predicate devices (e.g., K041114, K041586, K051995, K052915, K053588, K060358, K080663, K081090, K091423, and K100866 for indications; K021346 and K012091 for overall device). Intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with specific conditions. Also for revision procedures. |
| Biocompatibility | Implied by the use of ASTM F620 Titanium alloy and conformity to "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement" (April 28, 1994). Specific test results or criteria are not detailed in this summary, but these are standard considerations for such devices. |
| Sterility | As a single-use component, sterility would be an inherent requirement, but no specific testing details or criteria are mentioned in this summary. It would be part of general manufacturing and regulatory compliance. |
| Range of Sizes | Offered in the same range of sizes as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" for this device, as described, primarily refers to non-clinical (bench) testing performed on the device itself, comparing its physical and mechanical properties to established standards and predicate devices.
- Sample Size: Not explicitly stated for each test, but standard engineering tests would involve a sufficient number of samples to ensure statistical validity for the specific test (e.g., typically N=3 to N=5 or more for destructive tests like fatigue).
- Data Provenance: The tests are performed on the manufactured PROFEMUR® Z Titanium Plasma Sprayed Hip Stem. This is prospective testing of the device's physical samples. No human or animal data is described for these non-clinical tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable in the context of this 510(k) submission. The "ground truth" for the non-clinical tests is established by recognized international standards (ISO, ASTM) and the specifications of the predicate device, not by expert medical opinion on a test set.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication typically refers to the process of resolving discrepancies in expert human reviews for clinical or image-based studies. For non-clinical tests, compliance with standard test methods and evaluation against defined specifications are the "adjudication" mechanism.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was done. This device is a mechanical implant, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No standalone algorithm performance study was done. This device is a mechanical implant, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is based on:
- Engineering Standards: ISO 7206-4, 6, and 8 (for fatigue), ASTM F1875 (fretting corrosion), ASTM F2009 (axial disassembly), ASTM F1580 (titanium plasma spray coating).
- Predicate Device Specifications: The design, materials, and surface finish are compared directly to previously cleared predicate devices (e.g., K021346, K012091).
- WMT Specifications: Internal company specifications for manufacturing and coating application.
8. The Sample Size for the Training Set
There is no training set in the context of this 510(k) submission. This is not a machine learning or AI device. The process relies on demonstrating equivalence through engineering analysis and non-clinical testing.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set, this question is not applicable.
Summary of the Study Proving Acceptance Criteria (Substantial Equivalence):
The device's "acceptance" for market clearance (through 510(k)) is predicated on demonstrating substantial equivalence to legally marketed predicate devices. The "study" involves a comprehensive comparison and non-clinical testing program:
- Design & Material Comparison: A detailed analysis showing that the PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is identical in material (ASTM F620), substrate cross-sectional geometry, modular neck taper socket, and non-coated surface finish to predicate devices (K021346).
- Coating Equivalence: The titanium plasma spray coating is shown to conform to ASTM F1580, applied to WMT specifications, and is "identical" to the coating used on another cleared predicate (K012091). This is supported by testing referenced in a vendor Master File (though specific results are not included in this summary).
- Mechanical Performance Testing: The coated stem underwent standard fatigue tests (ISO 7206-4, 6, and 8) and fretting corrosion and axial disassembly force tests (ASTM F1875 and F2009). While specific pass/fail criteria or results are not detailed in this summary, the completion of these tests in accordance with relevant standards implicitly demonstrates that the device performs acceptably and equivalently to current standards for hip stems.
- Intended Use & Indications Equivalence: The device's intended use and indications for use are stated to be "identical" to existing Wright PROFEMUR® hip stems, which have multiple prior 510(k) clearances.
In essence, the study demonstrating "acceptance" for this device is the body of evidence provided in the 510(k) submission that systematically compares the new device against its predicates and relevant engineering standards, asserting that any differences do not raise new questions of safety or effectiveness. No clinical testing was provided to support this Class III modular hip stem.
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K111699(pg1/2)
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AUG 1 9 2011
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 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the PROFEMUR® Z Titanium Plasma Sprayed Hip Stem.
| (a)(1) Submitted BySubmitter's Name: | Wright Medical Technology, Inc.5677 Airline Rd. Arlington, TN 38002800-238-7188 (phone), 901-867-4190 (fax) |
|---|---|
| Date: | August 19, 2011 |
| Contact Person: | Gregory NealRegulatory Affairs Specialist II |
| (a)(2) Device NameProprietary Name: | PROFEMUR® Z Titanium Plasma Sprayed HipStem |
| Common Name: | Hip Stem |
| Classification Name and Reference: | 21 CFR 888.3320 Hip joint metal/metal semi-constrained, with an uncemented acetabularcomponent, prosthesis Class III |
| Subject Device Product Code and Panel Code: | Orthopedics/87/ JDL, KWA, LPH, LZO |
| (a)(3) Predicate DevicePredicate Proprietary Name:Predicate Classification and Number: | STEM Hip Replacement System888.3358 LPH Hip joint metal/polymer/ metal semi-constrained porous-coated uncemented prosthesisClass II (510k-K021346) |
| PRO-FEMUR Hip System888.3353 LZO Hip joint metal/ceramic/polymersemi-constrained cemented or nonporous uncementedprosthesis Class II (510k-K012091) | |
| Metal TRANSCEND Articulation System888.3320 JDL Hip joint metal/metal semi-constrained, with a cemented acetabular componentprosthesis Class III | |
| 888.3330 KWA Hip joint metal/metal semi-constrained, with an uncemented acetabularcomponent prosthesis Class III (510k-K004043) |
(a)(4) Device Description
The modular PROFEMUR® Z Titanium Plasma Sprayed hip stem is an uncemented distal femoral implant designed to couple with Wright Medical Technology's PROFEMUR® CoCr modular necks. The stem design was developed from the previously marketed PROFEMUR® Z Hip Stem ('STEM' K021346) and features the identical modular neck taper socket and is made of the identical Titanium alloy (ASTM F620) as previous hip stem designs by Wright.
The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem leatures the identical substrate cross-sectional geometry
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as the PROFEMUR® Z Hip Stem (K0213146) with the addition of titanium plasma spray coating conforming to ASTM F1580 applied according to WMT specifications which covers the proximal 1/3 of the stem.
(a)(5) Intended Use of the Device
Intended Use
The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use
- 1, 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 PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is a single use component, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.
(a)(6) Technological Characteristics of the Device
The indications for use for the PROFEMUR® Z Titanium Plasma Sprayed are identical to those for all existing Wright PROFEMUR® hip stems. The indications are applied to all PROFEMUR® hip stems and have been cleared in 510(k)s: K041114, K041586, K051995, K052915, K053588, K060358, K080663, K081090, K091423, and K100866.
The PROFEMUR® Z Titanium Plasma Sprayed Stem is identical in design and manufactured from the same forged Titanium Alloy (ASTM F620) as the PROFEMUR® Z Hip Stem ('STEM Hip Replacement System' K021346). The subject device has titanium plasma spray coating on the proximal 1/3of its surface, is offered in the same range of sizes, has the same features, and has the same intended use (non-cemented total hip replacement) as the predicate device. The titanium plasma spray coating to WMT specifications. The titanium plasma sprav coating is identical to the plasma spray coating used on the PRO-FEMUR Hip System (K012091). The surface finish of the non-coated portions of the PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is identical to the PROFEMUR® Z Hip Stem ('STEM Hip Replacement System' K021346),
(b)(1) Nonclinical Testing
The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem conforms to the Guidance for Industry and FDA Staff titled "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement" issued April 28, 1994. The titanium plasma spray coating used for the PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is verified by tesent within a vendor Master File. The coated stem was evaluated in distal and proximal fatigue tests according to ISO 7206-4, 6, and 8. Fretting corrosion and axial disassembly force of the coated stem were evaluated according to ASTM F1875 and F2009. Titanium Plasma Spray Coating is applied according to WMT specification and is identical to the titanium plasma spray used for the previously cleared PRO-FEMUR Hip System (K012091).
(b)(2) Clinical Testing
Clinical data was not provided for the class III modular hip stem.
(b)(3) Conclusions
The indications for use of the PROFEMUR® Z Titanium Plasma Sprayed are identical to the previously cleared predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the subject device has not changed relative to the predicate devices. The safety and effectiveness of the PROFEMUR® Z Titanium Plasma Sprayed is adequately supported by the substantial equivalence information, and analysis data provided within this Premarket Notification.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Wright Medical Technology, Inc. % Mr. Gregory Neal Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
AUG 1 9 2011
Re: K111699
Trade/Device Name: PROFEMUR® Z Titanium Plasma Sprayed Hip Stem Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, JDL, LPH, LZO Dated: July 21, 2011 Received: July 22, 2011
Dear Mr. Neal:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page - 2 - Mr. Gregory Neal
comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803): vood 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Device Name: PROFEMUR® Z Titanium Plasma Sprayed Hip Stem
Indications For Use:
The PROFEMUR® Z Titanium Plasma Sprayed 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.
- revision procedures where other treatments or devices have failed 4.
The PROFEMUR® Z Titanium Plasma Sprayed Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.
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)
Page 1 of 1
(Division Sign-off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111699
§ 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.