(160 days)
Not Found
No
The summary describes a mechanical hip stem and its mechanical testing, with no mention of AI or ML.
Yes.
The device is a hip stem intended for use in total hip arthroplasty to reduce pain and improve hip function, which are therapeutic goals.
No
Explanation: The device, Preserve Hip Stems, is described as being "intended for use in uncemented total hip arthroplasty for reduction or relief of pain and/or improved hip function". This indicates it is a surgical implant designed to treat conditions, rather than to diagnose them.
No
The device description clearly states it is a physical hip stem manufactured from Ti alloy and evaluated via mechanical testing, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "uncemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients." This describes a surgical implant used directly in the body to treat a physical condition.
- Device Description: The description details a "short modular hip stem" made of Ti alloy, designed for surgical implantation.
- 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. The evaluation methods described are mechanical testing, not biological or chemical analysis of patient samples.
Therefore, the Preserve Hip Stem is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Preserve Hip Stems are intended for use in uncemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
- 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
Product codes (comma separated list FDA assigned to the subject device)
KWA, JDL, LZO
Device Description
The Preserve stems are short modular hip stems that couple with modular necks. Design features of the stems are summarized below:
Cementless stem with proximal cpTi plasma spray coating
Available in 9 sizes (4-12)
Manufactured from Ti alloy
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Skeletally mature patients
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 Preserve Hip Stems were evaluated via mechanical testing; including fatigue, fretting; and distraction evaluation. A review of these results indicates that the Preserve Hip Stems are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.
The Preserve Hip Stems have been tested in distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K100866, K091423, K060358, K021346, K012091
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).
Not Found
§ 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.
0
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, this information serves as a Summary of Safety and Effectiveness for the use of the PROFEMUR® Preserve Hip Stems.
Submitted By:
Date:
Contact Person:
Proprietary Name:
Common Name:
Classification Name and Reference:
Subject Product Code and Panel Code:
Predicate Devices Name and Number:
Predicate Classification and Number:
Wright Medical Technology, Inc. 5677 Airline Rd, Arlington TN, 38002 (800) 238-7188
July 14, 2011
Matt Paul Project Regulatory Affairs Specialist
Preserve Hip Stems
Hip Stem
21 CFR 888.3330 Hip joint metal/metal semiconstrained, with an uncemented acetabular component prosthesis Class III
Orthopedics/87/KWA, JDL, LZO
PROFEMUR® Hip System Modular Necks PROFEMUR® TL Hip Stem. PROFEMUR® Z (STEM) PRO-FEMUR® Hip System
510(k): K100866, K091423, K060358, K021346, K012091
Orthopedics/87/ KWA, 888.3330
DEVICE INFORMATION
A. Device Description
The Preserve stems are short modular hip stems that couple with modular necks. Design features of the stems are summarized below:
- . Cementless stem with proximal cpTi plasma spray coating
- Available in 9 sizes (4-12)
- Manufactured from Ti alloy
The Preserve Hip Stems were evaluated via mechanical testing; including fatigue, fretting; and distraction evaluation. A review of these results indicates that the Preserve Hip Stems are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.
1
K1120500
B. Intended Use
The Preserve Hip Stems are intended for use in uncemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use
-
- 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
C. Technological Characteristic of the Device
The Preserve Hip Stem has the same technological characteristics as the predicate devices. Preserve Hip Stems are straight uncemented hip stems with a modular design. They feature both a triple tapered design and a proximal medial curvature. The proximal portion is coated with a commercially pure titanium plasma spray (conforming to ASTM F1580) that decreases distally in thickness. The materials used for the Preserve® Hip Stems are identical to the materials used for the predicate devices.
D. Nonclinical Testing
The Preserve Hip Stems have been tested in distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8.
E. Clinical Testing
Clinical data was not provided for the class III hip stem.
F. Conclusions
The indications for use of the Preserve Hip Stems 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 modified devices has not changed relative to the predicate devices. The safety and effectiveness of the Preserve Hip Stem is adequately supported by the substantial equivalence information, materials information, and analysis data 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 & Human Services. The logo consists of a stylized depiction of an eagle or bird with three wing-like shapes, positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the left side of the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. % Mr. Matt Paul 5677 Airline Rd Arlington TN, 38002
DEC 2 8 2011
Re: K112080
Trade/Device Name: Preserve Hip Stems 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, LZO Dated: December 22, 2011 Received: December 23, 2011
Dear Mr. Matt Paul:
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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Matt Paul
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.
Sincerely yours,
Mark N Mulkerso
Mark N. Melkerson Director Division of Surgical, Orthopedic & Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KII 2080
Indications for Use
510(k) Number (if known):
Device Name: PRESERVE Hip Stems
Indications For Use:
-
- 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 Preserve hip stem is intended for cementless hip arthroplasty.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
ulu l'hosse
510(k) Number K112080
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