(184 days)
The Restoration® Modular Hip System is indicated for use in:
- Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis; o
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and ●
- . Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indications specific to the Restoration Modular Hip System:
The Restoration® Modular Hip System is intended to be used for primary and revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur.
The Restoration® Modular Hip System is a bowed shaped femoral distal stem which is plasmasprayed with commercially pure titanium and coated with PureFix™ hydroxylapatite (HA). The device (6276-5-6XX) is available in stem diameters 11-26 mm and length 317 mm. The design of the device is identical to the bowed plasma distal stem cleared under the predicate device 510(k)s.
A Thermoplastic Polyurethane (TPU) sleeve will be added to the previously cleared packaging configuration and the thickness of the outer carton (cardboard box) will be increased. No changes will be made to the previously cleared sterile barrier materials.
This document is a 510(k) Premarket Notification for the Restoration® Modular Hip System by Stryker Orthopaedics. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against pre-defined acceptance criteria for a new AI/software-based medical device.
Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be found in this document for the Restoration® Modular Hip System.
The document explicitly states:
- "Non-clinical testing was not required as a basis for substantial equivalence."
- "Clinical testing was not required as a basis for substantial equivalence."
The "testing" mentioned in the document is related to packaging modifications and pyrogenicity for the physical device, not performance relative to clinical efficacy or diagnostic accuracy.
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Stryker Orthopaedics Nora O'connor Staff Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K193233
Trade/Device Name: Restoration® Modular Hip 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 , JDI, KWL, KWY, KWZ, LWJ, LZO, MAY, MBL, MEH Dated: April 24, 2020 Received: April 29, 2020
Dear Nora O'Connor:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
May 27, 2020
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
FOR Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K193233
Device Name Restoration® Modular Hip System
Indications for Use (Describe)
- · Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- · Rheumatoid arthritis;
- · Correction of functional deformity;
- · Revision procedures where other treatments or devices have failed; and,
· Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indications specific to the Restoration Modular Hip System:
The Restoration® Modular Hip System is intended to be used for primary and revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Special 510(k) 510(k) Summary
Restoration® Modular Hip System
510(k) SUMMARY
| Name and Address ofSponsor and Distributor | Stryker Orthopaedics325 Corporate DriveMahwah, NJ 07430Site Registration Number: 2249697 |
|---|---|
| Name and Address ofManufacturing Site(s) | Stryker Ireland Ltd. OsteonicsTullagreen BuildingIDA Business & Technology ParkCarrigtwohill, Cork,IrelandT45 HE42Site Registration Number: 9616680 |
| Contact Person: | Nora O'ConnorStaff Regulatory Affairs SpecialistStrykerTullagreen BuildingIDA Business & Technology ParkCarrigtwohill, Cork,IrelandT45 HE42 |
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Restoration® Modular Hip System
| Phone: 00353-214532529 | |
|---|---|
| Email: nora.oconnor@stryker.com | |
| Date Prepared: | May 18, 2020 |
| Proprietary Name: | Restoration® Modular Hip System |
| Common orUsual Name: | Total Hip Joint Replacement |
| Classification Name and Reference: | Hip joint metal/polymer/metal semi-constrained |
| porous-coated uncemented prosthesis, 21 CFR | |
| §888.3358 | |
| Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis, 21CFR §888.3353 | |
| Hip joint metal/polymer semi-constrained cementedprosthesis, 21 CFR §888.3350 | |
| Hip joint metal/polymer constrained cemented oruncemented prosthesis, 21 CFR §888.3310 | |
| Hip joint femoral (hemi-hip) metallic cemented oruncemented prosthesis, 21 CFR §888.3360 | |
| Hip joint femoral (hemi-hip) metal/polymercemented or uncemented prosthesis, 21 CFR§888.3390 | |
| Product Codes: | 87LPH, 87JDI, 87KWL, 87KWY, 87KWZ, 87LWJ,87LZO, 87MAY, 87MBL, 87MEH |
| Regulatory Class: | Class II |
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Restoration® Modular Hip System
Legally Marketed Predicate Device to Which Substantial Equivalence is Claimed:
- Howmedica Osteonics Hip Systems K121308 ●
- Howmedica Osteonics Restoration Modular System K022549 ●
- Howmedica Osteonics 2 Piece Modular Hip Stem - K013106
Device Description
The Restoration® Modular Hip System is a bowed shaped femoral distal stem which is plasmasprayed with commercially pure titanium and coated with PureFix™ hydroxylapatite (HA). The device (6276-5-6XX) is available in stem diameters 11-26 mm and length 317 mm. The design of the device is identical to the bowed plasma distal stem cleared under the predicate device 510(k)s.
A Thermoplastic Polyurethane (TPU) sleeve will be added to the previously cleared packaging configuration and the thickness of the outer carton (cardboard box) will be increased. No changes will be made to the previously cleared sterile barrier materials.
Intended Use
There is no change to the intended use for the subject device.
Indications for Use:
The Restoration® Modular Hip System is indicated for use in:
- Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis; o
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and ●
- . Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indications specific to the Restoration Modular Hip System:
The Restoration® Modular Hip System is intended to be used for primary and revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur.
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Summary of Technological Characteristics
The subject device is identical in intended use, indications for use, product design, product materials, operational principles and sterile barrier materials as the predicate device. The subject device is different from the predicate device in terms of the packaging configuration. A TPU sleeve will be added to the packaging configuration. The thickness of the outer carton will be increased.
Non-Clinical Testing
There have been no changes made to the device design or device materials. Non-clinical testing was not required as a basis for substantial equivalence.
A ship test study was completed on the subject device to qualify the introduction of the TPU sleeve to the packaging configuration. A compression test was included as part of the ship to qualify the increase in thickness of the outer carton on the subject device. Testing was completed as per ISO 11607-1, ASTM F1886, ASTM F88, ASTM F1929, and ASTM D4169.
Bacterial Endotoxin Testing (BET) as specified in ANSI/AAMI ST72:2011 was used for pyrogenicity testing on the subject device to meet an endotoxin limit of <20 Endotoxin Units (EU)/device.
Clinical Testing
Clinical testing was not required as a basis for substantial equivalence.
Conclusion
The Restoration® Modular Hip System is substantially equivalent in intended use, indications for use, product design, product materials, operational principles and sterile barrier materials to the predicate device. The proposed modifications do not affect safety or effectiveness.
§ 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.