(30 days)
Not Found
Not Found
No
The summary describes a mechanical hip implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
Explanation: The device is intended for use in total hip arthroplasty to reduce pain and improve hip function in patients with various degenerative joint diseases and deformities, which directly addresses therapeutic goals.
No
The PROFEMUR® Tapered Hip Stem is a surgical implant used for total hip arthroplasty, which is a treatment for conditions affecting the hip joint. It is not designed to diagnose or identify diseases or conditions.
No
The device description clearly outlines physical components of a hip stem implant, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total hip arthroplasty, addressing conditions like osteoarthritis and rheumatoid arthritis. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details the physical characteristics of a hip stem, a medical device implanted during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical implant used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The PROFEMUR® Tapered 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.
Product codes (comma separated list FDA assigned to the subject device)
LWJ, JDI, LZO, JDL, KWA
Device Description
The design features of the PROFEMUR® Tapered Hip Stem are summarized below:
- Modular neck taper
- Tapered cylindrical distal stem
- Plasma Sprayed proximal body
- Grit blasted distal stem
- Polished bullet tip
- Spines.
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)
Not Found
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.
Not Found
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
§ 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with a cemented 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. This generic type of device is limited to those prostheses intended for use with 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 a cemented 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 a cemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
K04/1114
Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in bold, black letters. Underneath the word is a design of three horizontal lines that are stacked on top of each other. In the upper right corner of the image, there is a handwritten note that says "p. 1/2".
MAY 2 8 2004
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 PROFEMUR® Tapered Hip Stem.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | April 26, 2004 |
| Contact Person: | Katie Logerot |
| Regulatory Affairs Specialist II | |
| Proprietary Name: | PROFEMUR® Tapered Hip Stem |
| Common Name: | Hip Stem |
| Classification Name and Reference: | Prosthesis, hip, semi-constrained, metal/polymer, uncemented - Class II |
| 21CFR 888.3350 Hip joint metal/polymer, semi-constrained, cemented prosthesis - Class II | |
| Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented – Class II | |
| 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 | |
| Device Product Code and Panel Code: | Orthopedics/87/ LWJ, JDI, LZO, JDL, KWA |
DEVICE INFORMATION
A. INTENDED USE
The PROFEMUR® Tapered 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:
headquarters
| Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 901.867.9971 phone | www.wmt.com |
|---|---|
| international subsidiaries |
ariana 011.32.2.378.3905 Belgium 011-39-0250-678.227 Italy
905.826.1600 Canada 011.81.3.3536.0474 Japan 011.33.1.45.13.24.40 France 011.44.1463.721.404 UK
011.49.4161.745130 Germany
1
1
$$
\mathfrak{k} \circ \mathfrak{k} \mapsto \mathfrak{n} \mathfrak{k} \qquad \qquad \qquad \mathfrak{n} \circ \mathfrak{k}
$$
- 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, er
- revision procedures where other treatments or devices have failed 4.
B. DEVICE DESCRIPTION
The design features of the PROFEMUR® Tapered Hip Stem are summarized below:
- Modular neck taper ●
- Tapered cylindrical distal stem .
- Plasma Sprayed proximal body .
- Grit blasted distal stem .
- Polished bullet tip ●
- . Spines
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The indications for use and materials of the PROFEMUR® Tapered Hip Stem are identical to the PROFEMUR® Z Hip Stem. The design features of the PROFEMUR® Tapered Hip Stem are substantially equivalent to the PROFEMUR® Z Hip Stem, the PERFECTA® RS Hip Stem, and the PERFECTA® Plasma Sprayed Hip Stem. The safety and effectiveness of the PROFEMUR® Tapered Hip Stem 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 & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three horizontal lines that curve upwards, resembling a stylized human figure or a symbol of growth and progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 2004
Ms. Katie Logerot Regulatory Affairs Specialist II Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K04114
Trade/Device Name: PROFEMUR® Tapered Hip Stem Trace/Device Name: 1 ROPERTOS: 200, 21 CFR 888.3330, 21 CFR 888.3350, and 21CFR 888.3353
Regulation Names: Hip joint metal/metal semi-constrained, with a cemented acetabular Fift fount mount besis, Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis, Hip joint metal/polymer semi-constrained cemented prosthesis, Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis and Prosthesis, hip, semi-constrained, metal/polymer, uncemented
Regulatory Class: III Product Codes: JDL, KWA, JDI, LZO and LWJ Dated: April 26, 2004 Received: April 28, 2004
Dear Ms. Logerot:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for answers wior 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 (sec above) into cither 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 he 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
3
Page 2 - Ms. Katie Logerot
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 (Scctions 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) 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 (301) 594-4659. 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,
Mark A. Milliken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K041114
Indications for Use
510(k) Number (if known):
Device Name: PROFEMUR® Tapered Hip Stem
Indications For Use:
The PROFEMUR® Tapered 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
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)
Mull Mullus Page 1 of 1
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number