(70 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on changes to the Instructions for Use, not technological advancements.
Yes
The device is a joint replacement, which is used to treat various joint diseases and correct deformities, indicating its therapeutic purpose.
No
The device description indicates a change to the Instructions for Use for a joint replacement device. Joint replacement is a treatment, not a diagnostic procedure. The 'Indications for Use' describe conditions for which the joint replacement is indicated, which means these conditions would have already been diagnosed.
No
The 510(k) summary describes a modification to the Instructions for Use of a joint replacement device, which is a physical implant. It does not describe a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical procedure (joint replacement) to treat conditions affecting the hip joint. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a joint replacement component, which is an implantable medical device. The modification described is a change to the Instructions for Use for this implant.
- 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.
IVDs are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a replacement for a damaged joint.
N/A
Intended Use / Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
- . rheumatoid arthritis;
- . correction of functional deformity:
- femoral fracture; .
This device may also be indicated in the salvage of previously failed surgical attempts.
Product codes (comma separated list FDA assigned to the subject device)
KWA, JDI, KWL, KWY, KWZ, LPH, LWJ, LZO
Device Description
The modification consists of a change to the Instructions for Use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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)
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
§ 888.3330 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
Summary of Safety and Effectiveness
Date: January 23, 2007
Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Regulatory Affairs Specialist Phone: (512) 834-6255 Fax: (512) 834-6313 Email: Teffany Hutto@encoremed.com Trade Name: FMP™ Metal/Metal Acetabular Insert
Common Name: Acetabular Insert
Classification Name: Hip joint metal/metal semi-constrained, with an uncemented component, prosthesis per 21 CFR 888.3330
Description: The modification consists of a change to the Instructions for Use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.
Intended Use: Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
- . rheumatoid arthritis;
- . correction of functional deformity:
- femoral fracture; .
This device may also be indicated in the salvage of previously failed surgical attempts.
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same materials, design, indications, packaging, and sterilization.
1
Summary of Safety and Effectiveness
Date: January 23, 2007
Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Regulatory Affairs Specialist Phone: (512) 834-6255 Fax: (512) 834-6313 Email: Teffany Hutto@encoremed.com Trade Name: Metal/Metal Hip System
Common Name: Total Hip Prosthesis, Semi-Constrained
Classification Name: Hip joint metal/metal semi-constrained, with an uncemented component, prosthesis per 21 CFR 888.3330
The modification consists of a change to the Instructions for Use to minimize the Description: necessity for multiple IFU's and to update the contents to reflect current practice.
Intended Use: Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
- rheumatoid arthritis; .
- correction of functional deformity; .
- . femoral fracture;
This device may also be indicated in the salvage of previously failed surgical attempts.
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same materials, design, indications, packaging, and sterilization.
2
Summary of Safety and Effectiveness
Date: January 23, 2007
Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Regulatory Affairs Specialist Phone: (512) 834-6255 Fax: (512) 834-6313 Email: Teffany Hutto@encoremed.com Trade Name: CLP® Offset Total Hip System
Common Name: Total Hip Prosthesis, Semi-Constrained
Classification Name: Hip joint metal/metal semi-constrained, with an uncemented component, prosthesis per 21 CFR 888.3330
Description: The modification consists of a change to the Instructions for Use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.
Intended Use: Joint replacement is indicated for patients suffering from disability due to:
- . noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- . rheumatoid arthritis;
- . correction of functional deformity;
- femoral fracture; ●
This device may also be indicated in the salvage of previously failed surgical attempts.
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same materials, design, indications, packaging, and sterilization.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
APR 4 - 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Encore Medical, L.P. % Ms. Teffany Hutto Regulatory Affairs Specialist 9800 Metric Boulevard Austin, Texas 78758
Re: K070221
Trade/Device Name: FMP™ Metal/Metal Acetabular Insert; Metal/Metal Hip System; CLP® Offset Total Hip System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with uncemented acetabular component, prosthesis Regulatory Class: Class III Product Codes: KWA, JDI, KWL, KWY, KWZ, LPH, LWJ, LZO Dated: January 23, 2007 Received: January 24, 2007
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.
If your device is classified (see above) into either 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 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); 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.
4
Page 2 - Ms. Teffany Hutto
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. 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 (240) 276-0120 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Валере Внекитр
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: FMP™ Metal/Metal Acetabular Insert
Indications for Use:
FMPTM Metal/Metal Acetabular Insert Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
- rheumatoid arthritis; .
- correction of functional deformity; .
- femoral fracture; .
This device may also be indicated in the salvage of previously failed surgical attempts.
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)
Barbara Neelup
ision Sign-9 Division of General, Restorative, and Neurological Devices
510(k) Number K070221
Page 1 of 1
6
510(k) Number (if known):
Device Name: Metal/Metal Hip System
Indications for Use:
Metal/Metal Hip System Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
- · noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- rheumatoid arthritis; .
- correction of functional deformity; .
- femoral fracture; .
This device may also be indicated in the salvage of previously failed surgical attempts.
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)
Page 1 of 1
7
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: CLP® Offset Total Hip System
Indications for Use:
CLP® Offset Total Hip System Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of . the natural femoral head;
- rheumatoid arthritis; .
- correction of functional deformity; .
- femoral fracture; .
This device may also be indicated in the salvage of previously failed surgical attempts.
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)