(29 days)
K/DEN number: Not Found
No
The document describes a mechanical implant (acetabular shell and liner) and its intended use and materials. There is no mention of software, algorithms, or any technology related to AI or ML. The performance studies focus on mechanical properties.
Yes.
The device is intended for reconstruction of the articulating surface of the hip to address conditions like severe pain, degenerative joint disease, and rheumatoid arthritis, which are therapeutic interventions.
No
The device description indicates it is a component of a hip replacement system (Acetabular Shell and Liner), which is a prosthetic for treatment, not a tool for diagnosis.
No
The device description explicitly states the device is made of titanium alloy and polyethylene, which are physical materials, not software. The summary also describes non-clinical testing related to the physical properties of the shell and liner.
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 device used for surgical reconstruction of the hip joint. This is a therapeutic and structural device, not a diagnostic one.
- Device Description: The description details the materials and components of a hip implant (shell and liner), which are physical devices implanted in the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) or to provide information about a patient's health status through in vitro analysis.
- Performance Studies: The performance studies focus on the mechanical properties and structural integrity of the implant, not on diagnostic accuracy or analytical performance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Cross-Over Acetabular Shell and Liner are intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed total hip Arthroplasty.
The Cross-Over Acetabular Shell and Liner are used as part of the Provident Hip Systems. The components of this hip system are intended for cementless fixation.
Product codes
OOG, OOH, OQI, LPH, LWJ, JDI, MAY, LZO
Device Description
The Cross-Over Acetabular Shell and Liner will be used as part of a complete total hip system in conjunction with a femoral head and femoral stem in total hip arthroplasty.
The Cross-Over Acetabular Shell is made of titanium alloy with a commercially pure titanium plasma spray coating. The Cross-Over Liner is made of polyethylene blended with Vitamin E. The liner is available in both non-hooded and hooded options.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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
Non-clinical testing was performed on the Cross-Over Acetabular Shell and Liner to assess the interconnection mechanism between the shell and liner (i.e., disassembly force, lever-out torque, and rotational failure torque). The results of the performed tests demonstrate that the Cross-Over Acetabular Shell and Liner are substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Acetabular Shells in the Stelkast Provident Hip System (K001745), EXp Acetabular Liner (K094035)
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
K122773 - Page 1 of 2
ОСТ
9 2012
510(k) Summary
Device Trade Name:
Manufacturer:
Contact:
Cross-Over Acetabular Shell and Liner
StelKast, Inc. 200 Hidden Valley Road McMurray, PA 15317
Mr. David Stumpo Vice President of Product Development Phone: 724.731.2208 Fax: 724.941.5987 dstumpo@stelkast.com
1331 H Street NW, 12th Floor Washington, DC 20005 Phone: (202) 552-5800 Fax: (202) 552-5798 .
Musculoskeletal Clinical Regulatory Advisers, LLC
Prepared by:
Date Prepared:
September 7, 2012
Classification:
21 CFR 888.3358, Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis
Class:
Product Codes:
OOG, OOH, OQI, LPH, LWJ, JDI, MAY, LZO
Indications For Use:
The Cross-Over Acetabular Shell and Liner are intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal 4. femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip Arthroplasty.
II
The Cross-Over Acetabular Shell and Liner are used as part of the Provident Hip Systems. The components of this hip system are intended for cementless fixation.
1
Device Description:
The Cross-Over Acetabular Shell and Liner will be used as part of a complete total hip system in conjunction with a femoral head and femoral stem in total hip arthroplasty.
The Cross-Over Acetabular Shell is made of titanium alloy with a commercially pure titanium plasma spray coating. The Cross-Over Liner is made of polyethylene blended with Vitamin E. The liner is available in both non-hooded and hooded options.
Predicate Devices:
Comparative information presented in the 510(k) supports the substantial equivalence of the Cross-Over Acetabular Shell and Liner with respect to their indications for use, design, materials, and performance.
This 510(k) demonstrates the substantial equivalence of the Cross-Over Acetabular Shell and Liner to the following predicate devices:
- Acetabular Shells in the Stelkast Provident Hip System (K001745), and .
- . EXp Acetabular Liner (K094035)
These acetabular shells and liners have the same intended use and general design, are available in a similar size range, and are made of the same materials.
Preclinical Testing:
Non-clinical testing was performed on the Cross-Over Acetabular Shell and Liner to assess the interconnection mechanism between the shell and liner (i.e., disassembly force, lever-out torque, and rotational failure torque). The results of the performed tests demonstrate that the Cross-Over Acetabular Shell and Liner are substantially equivalent to tegally marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol resembling an eagle or bird in flight, rendered in a stylized, minimalist design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
ОСТ
2012
StelKast Company
% Mr. David Stumpo
Vice President of Product Development
200 Hidden Valley Road
McMurray, Pennsylvania 15317
Re: K122773 Trade/Device Name: Cross-Over Acetabular Shell and Liner 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: OQG. OQH, OQI, LPH, LWJ, JDI, MAY, LZO Dated: September 7, 2012 Received: September 13, 2012
Dear Mr. Stumpo:
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.
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
3
Page 2 - Mr. David Stumpo
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K122773
Device Name: Cross-Over Acetabular Shell and Liner
The Cross-Over Acetabular Shell and Liner are intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. .
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip Arthroplasty.
The Cross-Over Acetabular Shell and Liner are used as part of the Provident Hip Systems. The components of this hip system are intended for cementless fixation.
V Prescription Use (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)
signature
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_K122777