(211 days)
Not Found
No
The description focuses on the mechanical design and materials of a hip stem, with no mention of AI or ML capabilities.
Yes
The device, a "Modular Revision Femoral Hip Stem," is explicitly designed for musculoskeletal reconstruction (hip arthroplasty), indicating its role in treating and improving a patient's medical condition.
No
The provided text describes a Modular Revision Femoral Hip Stem, which is an implant used for revision hip arthroplasty in patients with poor bone stock. It is a treatment device, not a diagnostic one as it does not diagnose or detect medical conditions.
No
The device description clearly details a physical implant (femoral hip stem) made of titanium alloy, 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 states that the device is a "Modular Revision Femoral Hip Stem" for surgical implantation in patients undergoing revision hip arthroplasty. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description details the physical components of the hip stem (stem, neck, screw) and the materials used. It describes a mechanical device for surgical implantation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to in vitro testing.
Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Modular Revision Femoral Hip Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.
Product codes (comma separated list FDA assigned to the subject device)
KWA, LWJ, KWZ, LZO
Device Description
The Modular Revision Hip stem is made up of a modular stem coupled with a proper neck by means of a "Morse" taper stabilized during the implantation phase by a safety screw.
This system is particularly indicated for revision surgery on both uncemented and cemented femoral implants, when there is significant bone loss and an abnormal meta-epiphyseal anatomy of the femur. The modular system allows achievement of the required stability and the good distal fit of the stem within the femoral canal, regardless of the bone loss or the femur anatomy. In some particular cases the stem fixation can be enhanced by using bone cement.
The stems are made of titanium alloy (ASTM F1472). The stem has a 1°50' tapered profile, with round finned section and typical diameters ranging from 14 to 24 mm. The diameter increases by 2 mm.
The neck design, made of titanium alloy (ASTM F1472), includes a single CCD configuration of 135°, thus performing a unique offset of 35mm. An additional neck offset of 40mm of 131℃ of CCD configuration is also available. Both the neck versions are available in 7 different lengths from 50 to 110 mm. in 10 mm increments.
The correct length of the final implant can thus be obtained by coupling the stem to a modular neck.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral head, neck or portions of the proximal femur
Indicated Patient Age Range
Not Found
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)
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions.
Clinical Testing: None provided.
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.
K992667, K031572, K994038, K090757, K994126, K032709
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
K092331 #1/
Summary of Safety and Effectiveness
Date: March 2, 2010
Manufacturer: Encore Medical, L.P. Trade Name: DJO Surgical 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: teffany.hutto@djosurgical.com
| Product | Product Codes | Regulation and Classification Name |
|---|---|---|
| Modular Revision Hip Stem | KWA, LWJ, KWZ, LZO | Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis per 21 CFR 888.3330 |
Description:
The Modular Revision Hip stem is made up of a modular stem coupled with a proper neck by means of a "Morse" taper stabilized during the implantation phase by a safety screw.
This system is particularly indicated for revision surgery on both uncemented and cemented femoral implants, when there is significant bone loss and an abnormal meta-epiphyseal anatomy of the femur. The modular system allows achievement of the required stability and the good distal fit of the stem within the femoral canal, regardless of the bone loss or the femur anatomy. In some particular cases the stem fixation can be enhanced by using bone cement.
The stems are made of titanium alloy (ASTM F1472). The stem has a 1°50' tapered profile, with round finned section and typical diameters ranging from 14 to 24 mm. The diameter increases by 2 mm.
The neck design, made of titanium alloy (ASTM F1472), includes a single CCD configuration of 135°, thus performing a unique offset of 35mm. An additional neck offset of 40mm of 131℃ of CCD configuration is also available. Both the neck versions are available in 7 different lengths from 50 to 110 mm. in 10 mm increments.
The correct length of the final implant can thus be obtained by coupling the stem to a modular neck.
Intended Use: The Modular Revision Femoral Hip Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.
Predicate Devices:
ZMR 1M Hip System - Revision Taper - Zimmer - K992667, K031572 Modular REACH Hip - Biomet - K994038 Modular Femoral Revision System - Biomet - K090757 Modular-Plus Revision System - Plus Orthopedics - K994126, K032709
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same materials, and indications for use.
Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions.
Clinical Testing: None provided.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Encore Medical, L.P. % Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758
MAR - 3 2010
Re: K092331
Trade/Device Name: DJO Surgical Revision Femoral Hip System, 428-14/24-140/20 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, LWJ, KWZ, LZO Dated: February 25, 2010 Received: February 26, 2010
Dear Ms. Hutto:
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.
2
Page 2 – Ms. Teffany Hutto
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 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 A. Millikerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K092331
Device Name: Modular Revision Femoral Hip Stems
Indications for Use:
· Modular Revision Hip Stem Indications for Use
The Modular Revision Femoral Hip Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anita for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K192233/
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