(86 days)
Not Found
No
The device description and intended use focus on a mechanical implant for hip arthroplasty, with no mention of AI/ML capabilities or related performance metrics.
No
Explanation: This device is an implantable medical device used in total hip arthroplasty to treat conditions like degenerative joint disease or failed previous surgeries. While it's used in treatment, it's a structural component, not an active therapeutic agent or therapy delivery system in itself.
No.
The device is a surgical implant (acetabular reinforcement cup) used in total hip arthroplasty for treatment of specific joint conditions and failed surgeries. It is not designed to diagnose diseases or conditions.
No
The device description clearly states it is a "hemispherical acetabular reinforcement shell made of titanium alloy" and includes physical components like a fixation plate and hook, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Converge RETi-Lock Multi-Hole Reinforcement Cup is a physical implant made of titanium alloy designed to be surgically placed in the hip joint.
- Intended Use: Its intended use is for surgical treatment during total hip arthroplasty to address issues with the acetabulum. This is a surgical procedure, not a diagnostic test performed on a sample.
The information provided clearly describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The Converge RETi-Lock Multi-Hole Reinforcement Cup is intended for use in total hip arthroplasty for treatment of the following:
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis;
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists; ●
- . Revision of previously failed hip arthroplasty.
Product codes
LZO, KWA, JDI, LWJ
Device Description
The Converge RETi-Lock Multi-Hole Reinforcement Cup is a hemispherical acetabular reinforcement shell made of titanium alloy. It is designed to expand the surgeon's options for treatment in cases when acetabular bone stock is deficient. This device also has a fixation plate designed to match the contour of the ilium of the acetabulum and a hook designed to attach to the obturator foramen. Numerous screw holes in the cup and along the plate help to ensure fixation in good bone stock.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Reference Device(s)
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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
000049
OCT 2 4 2003
510(k) SUMMARY
| SPONSOR NAME: | Centerpulse Orthopedics, Inc.
9900 Spectrum Drive
Austin, TX 78717 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Robert M. Wolfarth
Phone: (512) 432-9324
E-Mail: Robert.Wolfarth@Centerpulse.com |
| TRADE NAME: | Converge RETi-Lock Multi-Hole Reinforcement Cup |
| COMMON NAME: | Non-porous, press-fit, acetabular shell system |
| CLASSIFICATION: | Non-porous, press-fit, acetabular shell systems (Product Codes 87
LZO, KWA, JDI, LWJ) are Class II per 21 CFR §§888.3353, .3330,
and .3350 respectively, reviewed by the Orthopedic Devices panel. |
PREDICATE DEVICES:
DEVICE DESCRIPTION:
The Converge RETi-Lock Multi-Hole Reinforcement Cup is a hemispherical acetabular reinforcement shell made of titanium alloy. It is designed to expand the surgeon's options for treatment in cases when acetabular bone stock is deficient. This device also has a fixation plate designed to match the contour of the ilium of the acetabulum and a hook designed to attach to the obturator foramen. Numerous screw holes in the cup and along the plate help to ensure fixation in good bone stock.
INTENDED USE:
The Converge RETi-Lock Multi-Hole Reinforcement Cup is intended for use in total hip arthroplasty for treatment of the following:
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
- . Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
- . Revision of previously failed hip arthroplasty.
BASIS OF SUBSTANTIAL EQUIVALENCE:
Performance testing, design comparisons, and functional analyses conducted on the Converge RETi-Lock Multi-Hole Reinforcement Cup demonstrate that this device is substantially equivalent to the predicate devices.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2003
Mr. Robert M. Wolfarth Regulatory Affairs Programs Manager Centerpulse Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717
Re: K032348
Trade/Device Name: Converge RETi-Lock Multi-Hole Reinforcement Cup Regulation Numbers: 21 CFR 888.3353; 21 CFR 888.3330; 21 CFR 888.3350 Regulation Names: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis; Hip joint metal/metal semiconstrained, with an uncemented acetabular component, prosthesis; Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II, III, II Product Codes: LZO, KWA, JDI, LWJ Dated: July 29, 2003 Received: July 31, 2003
Dear Mr. Wolfarth:
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
2
Page 2 - Mr. Robert M. Wolfarth
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.
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.
Sincerely, yours,
Mark A. Millman
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
3
Indications For Use
510(K) Number:
Device Name:
Converge RETi-Lock Multi-Hole Reinforcement Cup
Indications for Use:
The Converge RETi-Lock Multi-Hole Reinforcement Cup is intended for use in total hip arthroplasty for treatment of the following:
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis;
- Those patients with failed previous surgery where pain, deformity, or dysfunction persists; ●
- . Revision of previously failed hip arthroplasty.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ OR Over-The-Counter Use _
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
for Mark n Melleur
(Division Sign-Off)
ion of General, Restorative
Neurological Devices
K032348