(73 days)
No
The device description and performance studies focus on the mechanical properties and design of a hip implant, with no mention of AI or ML technology.
Yes
The device treats "painful, disabling joint disease of the hip," indicating it is used for therapeutic purposes such as Total Hip Arthroplasty.
No
Explanation: The provided text describes the Restoration® Anatomic Shell, which is an implant for Total Hip Arthroplasty. Its intended use is for treating painful, disabling joint disease and for revision surgeries. The device description details its design, materials, and compatibility, all of which point to it being a therapeutic or restorative device, not one used for diagnosis.
No
The device description clearly details a physical implant made of Ti-6Al-4V ELI alloy with a porous CP-Ti coating, intended for surgical implantation in the hip. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Restoration Anatomic Shell is an implantable device intended for cementless fixation into a prepared acetabulum during Total Hip Arthroplasty. This is a surgical procedure involving the replacement of a joint, not a diagnostic test performed on a sample.
- Intended Use: The intended use describes the conditions for which the hip replacement is indicated (e.g., degenerative arthritis, rheumatoid arthritis). This is a therapeutic use, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or any other activity typically associated with in vitro diagnostics.
Therefore, the Restoration Anatomic Shell is a medical device (specifically, an implantable orthopedic device), but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other . procedure.
- . Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques ● as indicated by deficiencies of the acetabulum.
The Restoration® Anatomic Shell is indicated for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
LPH
Device Description
The Restoration Anatomic Shell is intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The basic design of the Restoration Anatomic Shell is similar to two other commercially available total hip systems, which are Stryker Orthopaedics' Trident Porous Titanium Acetabular Shell, and DePuy's S-ROM Oblong Cup. The Restoration Anatomic Shell will be available in 14 sizes, 54mm - 80mm diameter in 2mm increments. There will be a left and right shell configuration for each size. The subject device is designed to accept the existing Modular Dual Mobility (MDM) liners. The locking mechanism is identical to the locking mechanism of the predicate Trident Porous Titanium Acetabular Shell. The implant will be made of Ti-6Al-4V ELI alloy (ASTM F136) and will have a porous Commercially Pure (CP)-Ti (ASTM F1580) coating allowing for biological fixation. The inner locking mechanism is positioned eccentrically relative to the outer surface of the shell, thus creating a build-up of solid material intended to be positioned in the superior region of the acetabulum. The area outside the locking mechanism will have a recessed or beveled surface to reduce the amount of implant that is exposed outside of the native acetabulum. The shell will have multiple screw hole options located in the superior and inferior regions of the shell as well as peripheral screw holes located outside the locking mechanism. The Restoration Anatomic Shell is compatible with the optional currently marketed Stryker Orthopaedics Acetabular Dome Hole Plug made from CP Titanium (ASTM F-67).
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
Prescription Use
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: The following non-clinical laboratory testing was performed to determine substantial equivalence:
-
- Push-out Test of a Modular Dual Mobility Liner in a Deformed Shell
-
- Acetabular Wedge Augment Device Fatigue Model
-
- Mechanical Properties of the Tritanium Foam Coating
-
- Material Microstructure, Composition, and Trace Elemental Analysis of the Substrate and Surface of the Tritanium Acetabular Shells
-
- Structural Characteristics of the Tritanium Foam Coating
Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.
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.
Trident Porous Titanium Acetabular Shell (K010170), S-ROM Oblong Cup (K905258)
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
§ 888.3358 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 14, 2014
Stryker Orthopaedics Ms. Denise Daugert Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K142462 Trade/Device Name: Restoration Anatomic Shell 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: August 29, 2014 Received: September 2, 2014
Dear Ms. Daugert:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Denise Daugert
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K142462
Device Name: Restoration Anatomic Shell
Indications for Use:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other . procedure.
- . Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques ● as indicated by deficiencies of the acetabulum.
The Restoration® Anatomic Shell is indicated for cementless use only.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
AND/OR
| Over-The-Counter Use
| (21 CFR 807 Subpart C) | |
|---|---|
| ------------------------------------------------ | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
3
510(k) Summary
| Sponsor | Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430 | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person | Denise Daugert
Sr. Regulatory Affairs Specialist
Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430
P: (201) 831 5413
F: (201) 831 4413 | |
| Alternate Contact: | Patricia Sett-LaPerch
Manager, Regulatory Affairs
Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430
P: 201 831 5938
F: 201 831 4938 | |
| Date Prepared: | August 29, 2014 | |
| Proprietary Name: | Restoration Anatomic Shell | |
| Common Name: | Total Hip Joint Replacement | |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coated
uncemented prosthesis. (888.3358) | |
| Product Codes: | LPH | |
Legally Marketed Device to Which Substantial Equivalence is claimed:
Device Description:
The Restoration Anatomic Shell is intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The basic design of the Restoration Anatomic Shell is similar to two other commercially available total hip systems, which are Stryker Orthopaedics' Trident Porous Titanium Acetabular Shell, and DePuy's S-ROM Oblong
4
Cup. The Restoration Anatomic Shell will be available in 14 sizes, 54mm - 80mm diameter in 2mm increments. There will be a left and right shell configuration for each size. The subject device is designed to accept the existing Modular Dual Mobility (MDM) liners. The locking mechanism is identical to the locking mechanism of the predicate Trident Porous Titanium Acetabular Shell. The implant will be made of Ti-6Al-4V ELI alloy (ASTM F136) and will have a porous Commercially Pure (CP)-Ti (ASTM F1580) coating allowing for biological fixation. The inner locking mechanism is positioned eccentrically relative to the outer surface of the shell, thus creating a build-up of solid material intended to be positioned in the superior region of the acetabulum. The area outside the locking mechanism will have a recessed or beveled surface to reduce the amount of implant that is exposed outside of the native acetabulum. The shell will have multiple screw hole options located in the superior and inferior regions of the shell as well as peripheral screw holes located outside the locking mechanism. The Restoration Anatomic Shell is compatible with the optional currently marketed Stryker Orthopaedics Acetabular Dome Hole Plug made from CP Titanium (ASTM F-67).
Intended Use: The Restoration Anatomic Shell is intended for use in total hip arthroplasty and is intended for either primary or revision Total Hip Arthroplasty.
Indications for Use:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other . procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques . are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques . as indicated by deficiencies of the acetabulum.
The Restoration Anatomic Shell is indicated for cementless use only.
5
Summary of Technological Characteristics: Device Comparisons show that the Restoration Anatomic Shell is substantially equivalent to its predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles.
Non-Clinical Testing: The following non-clinical laboratory testing was performed to determine substantial equivalence:
-
- Push-out Test of a Modular Dual Mobility Liner in a Deformed Shell
-
- Acetabular Wedge Augment Device Fatigue Model
-
- Mechanical Properties of the Tritanium Foam Coating
-
- Material Microstructure, Composition, and Trace Elemental Analysis of the Substrate and Surface of the Tritanium Acetabular Shells
-
- Structural Characteristics of the Tritanium Foam Coating
Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.
Conclusion: The Restoration Anatomic Shell is substantially equivalent to the predicate devices identified in this premarket notification.