(89 days)
Not Found
No
The document describes a hip implant and its components, focusing on materials, design, and mechanical testing. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes.
The device is a medical implant (acetabular shell) used in total hip arthroplasty to treat painful and disabling joint diseases, restore function, and alleviate symptoms, which are all therapeutic aims.
No
The device description indicates it is a sterile, single-use device intended for cementless fixation into a prepared acetabulum for total hip arthroplasty, and the indications for use describe conditions for hip replacement. None of these functions involve diagnosis.
No
The device description clearly states it is a sterile, single-use device manufactured from Ti-6Al-4V ELI alloy with a porous CP-Ti coating, indicating it is a physical implant, not software.
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 for surgical implantation to treat painful and disabling joint disease of the hip. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a "sterile, single-use device that is intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty." This is a description of a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Painful, disabling joint disease of the hip from: degenerative arthritis, theumatoid 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 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.
When used with MDM Liners
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Dislocation risks
When used with Constrained Liner:
The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
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 a sterile, single-use device that is intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The subject device substrate is manufactured from Ti-6Al-4V ELI alloy and has a porous CP-Ti coating. The materials, design features and screw hole locations of the Restoration Anatomic Shell are identical to the primary predicate device cleared in K142462. The purpose of this submission is to add compatibility of Trident Polyethylene Liners and clarify the indications for use for specific compatible liners.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip, acetabulum, femoral neck, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: The following non-clinical laboratory testing has been provided to determine substantial equivalence:
- Lever-out Test of a Trident Polyethylene Liner in a Trident Shell
- Push-out Test of a Trident Polyethylene Liner in a Trident Shell
- Lever-out Test of a Trident Constrained Polyethylene Liner in a Trident Shell
- Range of Motion for the Trident 0° Constrained Acetabular Liner
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.
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 features the department's name arranged in a circular fashion around a symbol. The symbol consists of a stylized caduceus with three human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 10, 2015
Stryker Orthopaedics Ms. Allison Ling Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K151264 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: July 8, 2015 Received: July 10, 2015
Dear Ms. Ling:
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 (reporting of medical device
1
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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,
Mark N. Melkerson -S
Mark 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)
Unknown K151264 (page 1 / 1)
Device Name
Restoration Anatomic Shell
Indications for Use (Describe)
· Painful, disabling joint disease of the hip from: degenerative arthritis, theumatoid 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 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.
When used with MDM Liners
· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
· Dislocation risks
When used with Constrained Liner:
· The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Restoration® Anatomic Shell is indicated for cementless use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
| Sponsor | Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Allison M. Ling
Regulatory Affairs Specialist
Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430
P: (201) 831 6520
F: (201) 831 3520 |
| 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: | May 12th, 2015 |
| 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:
- Primary: Restoration Anatomic Shell (K142462) ●
- . Secondary: Trident Porous Titanium Acetabular Shell (K010170)
Device Description:
The Restoration Anatomic Shell is a sterile, single-use device that is intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The subject device substrate is manufactured from Ti-6Al-4V ELI alloy and has a porous CP-Ti coating. The materials, design features and screw hole locations of the Restoration Anatomic
4
Shell are identical to the primary predicate device cleared in K142462. The purpose of this submission is to add compatibility of Trident Polyethylene Liners and clarify the indications for use for specific compatible liners.
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.
When used with MDM Liners
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.
- Dislocation risks 0
When used with Constrained Liner:
- The Trident Constrained Acetabular Insert is indicated for use in primary and revision o patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Restoration Anatomic Shell is indicated for cementless use only.
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.
5
Non-Clinical Testing: The following non-clinical laboratory testing has been provided to determine substantial equivalence:
-
- Lever-out Test of a Trident Polyethylene Liner in a Trident Shell
-
- Push-out Test of a Trident Polyethylene Liner in a Trident Shell
-
- Lever-out Test of a Trident Constrained Polyethylene Liner in a Trident Shell
-
- Range of Motion for the Trident 0° Constrained Acetabular Liner
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.