(89 days)
Not Found
Not Found
No
The device description focuses on the physical components and design features of an acetabular cup system, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for primary or revision reconstruction of the acetabular portion of hip joints, addressing conditions such as NIDJD, IJD, and failed hip arthroplasty, and is therefore used to alleviate symptoms and restore function.
No
The provided text describes a medical device, the Renewal™ Acetabular Cup System, which is an implant used for hip reconstruction. It details its components, design features, and intended surgical use, but there is no mention of it being used to diagnose conditions or process diagnostic information.
No
The device description explicitly states it consists of "metal acetabular shells and UHMWPE acetabular liners," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for the reconstruction of the acetabular portion of the hip joint. This is a device used in vivo (within the body) for treatment.
- Device Description: The description details physical components like metal shells and plastic liners, which are typical of orthopedic implants.
- 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 compatibility testing.
IVD devices are used to perform tests outside the body on biological samples. This device is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
The Renewal™ Acetabular Cup System is intended for primary or revision reconstruction, with or without bone cement, of the acetabular portion of severely disabled and/or very painful hip joints, where radiographic evidence of sufficient sound bone is present. Clinical Indications for Use are:
-
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory joint disease (IJD), e.g., rheumatoid arthritis;
- patients with failed previous surgery where pain, deformity, or dysfunction 3. persists;
-
- revision of previously failed hip arthroplasty; and
-
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The Renewal™ Acetabular Cup System components are single use components intended for use in conjunction with associated metal or ceramic femoral heads as part of an uncemented or cemented total hip arthroplasty.
Product codes
LPH
Device Description
The Renewal™ Acetabular Cup System consists of metal acetabular shells and UHMWPE acetabular liners.
The Renewal™ Acetabular Shell will be available in a hemispherical titanium alloy shell with and without a 2 mm peripheral rim flare. The shells will be coated with commercially pure titanium porous beads.
Design features of the Renewal™ Acetabular shell are summarized below:
- Total hemispherical design .
- Hemispherical design with a 2 mm peripheral flare .
- Coated with CPTi porous beads ●
- . No-Hole, 3-hole, 5-Hole, and 9-Hole options
- Threaded apical hole plug
The Renewal™ Acetabular Liners will be available with 0°, 10°, 15°, 20° overhangs with/without a 6+mm lateralized shift. The liner's internal geometry will be intended to be used with existing femoral heads manufactured from cobalt chrome or ceramic. The Renewal™ liner's external geometry will be designed to accept the Renewal™ Acetabular Shells.
Design features of the Renewal™ Acetabular Liner are summarized below:
- 360° liner overhang positioning options .
- Features an easy-to-assemble snap lock system to lock the liner into the shell .
- . The lip of the 10° and 20° liners will be full hemispheres
- The lip of the 15° liner will be machined to 180° .
- The liners will be offered with 0°, 10°, 15°, and 20° overhangs .
- The 0° and 10° liners will also be offered with a 6+mm lateralized shift ●
- Internal diameter will have a 2mm chamfer to minimize impingement. .
The thinnest part of any UHMWPE articulating insert will be greater than 4mm if attached to a metal backing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joints; acetabular portion; 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
APR 1 5 2002
510(k) Notification
Orthopaedic Innovations Renewal™ Acetabular Cup System
K020145
1 OF 2
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 use of the Renewal™ Acetabular Cup System.
Submitted By:
Date:
Contact Person:
Orthopaedic Innovations, Inc.
Renewal™ Acetabular Cup System
Metal/Polymer Acetabular Components
21 CFR 888.3358 Prosthesis, Hip, Semi-
January 2, 2002
Gregory M. Mercuri Director of R & D
Proprietary Name:
Common Name:
Classification Name and Reference:
Device Product Code and Panel Code:
Uncemented - Class II
Constrained, metal/polymer,
Orthopedics/87/LPH
DEVICE INFORMATION
Intended Use:
The Renewal™ Acetabular Cup System is intended for primary or revision reconstruction, with or without bone cement, of the acetabular portion of severely disabled and/or very painful hip joints, where radiographic evidence of sufficient sound bone is present. Clinical Indications for Use are:
-
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory joint disease (IJD), e.g., rheumatoid arthritis;
- patients with failed previous surgery where pain, deformity, or dysfunction 3. persists;
-
- revision of previously failed hip arthroplasty; and
-
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
1
The Renewal™ Acetabular Cup System components are single use components intended for use in conjunction with associated metal or ceramic femoral heads as part of an uncemented or cemented total hip arthroplasty.
K020145
20F2
Device Description:
The Renewal™ Acetabular Cup System consists of metal acetabular shells and UHMWPE acetabular liners.
The Renewal™ Acetabular Shell will be available in a hemispherical titanium alloy shell with and without a 2 mm peripheral rim flare. The shells will be coated with commercially pure titanium porous beads.
Design features of the Renewal™ Acetabular shell are summarized below:
- Total hemispherical design .
- Hemispherical design with a 2 mm peripheral flare .
- Coated with CPTi porous beads ●
- . No-Hole, 3-hole, 5-Hole, and 9-Hole options
- Threaded apical hole plug
The Renewal™ Acetabular Liners will be available with 0°, 10°, 15°, 20° overhangs with/without a 6+mm lateralized shift. The liner's internal geometry will be intended to be used with existing femoral heads manufactured from cobalt chrome or ceramic. The Renewal™ liner's external geometry will be designed to accept the Renewal™ Acetabular Shells.
Design features of the Renewal™ Acetabular Liner are summarized below:
- 360° liner overhang positioning options .
- Features an easy-to-assemble snap lock system to lock the liner into the shell .
- . The lip of the 10° and 20° liners will be full hemispheres
- The lip of the 15° liner will be machined to 180° .
- The liners will be offered with 0°, 10°, 15°, and 20° overhangs .
- The 0° and 10° liners will also be offered with a 6+mm lateralized shift ●
- Internal diameter will have a 2mm chamfer to minimize impingement. .
The thinnest part of any UHMWPE articulating insert will be greater than 4mm if attached to a metal backing.
Substantial Equivalence Information:
The intended use, material, type of interface, and design features of the Renewal™ Acetabular Cup System are substantially equivalent to the competitive devices previously cleared for market. The safety and effectiveness of the Renewal™ Acetabular Cup System are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping profiles, suggesting a sense of community or collaboration. The logo is rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 2002
Mr. Gregory M. Mercuri Director of Research & Development Orthopaedic Innovations, Inc. 6188 Olson Memorial Highway Golden Valley, Minnesota 55422
Re: K020145
Trade Name: Renewal™ Acetabular Cup System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: January 10, 2002 Received: January 16, 2002
Dear Mr. Mercuri:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
3
Page 2 - Mr. Gregory M. Mercuri
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
for Mark A. Wilkerson
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
Device Name: Renewal™ Acetabular Cup System
The Renewal™ Acetabular Cup System is intended for primary or revision reconstruction, with or without bone cement, of the acetabular portion of severely disabled and/or very painful hip joints, where radiographic evidence of sufficient sound bone is present. Clinical Indications for Use are:
-
- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory joint disease (IJD), e.g., rheumatoid arthritis;
-
- patients with failed previous surgery where pain, deformity, or dysfunction persists:
-
- revision of previously failed hip arthroplasty; and
AND ITE DE CHI THIC I THE
-
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
| DEADER INC. YANIE DEAZY THE LINE-CONTINUE VIY AND I ODA FA | ||
|---|---|---|
| Concurrence of CDRH, Office of Device Explugtion (ODE) | 510(k) Number - | vision Sign-Off) |
| Division of General. Restorative | ||
| and Neurological Devices | ||
| Prescription Use × | OR | Over-The-Counter Use |