(53 days)
The Restoration™ Modular System is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.
The 2 Piece Modular Hip Stem, hereby referred to as the Restoration™ Modular System, is a modular system comprised of a proximal body, distal stem, and locking bolt. These three individual components utilizing a modular junction are assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal This system is designed so that all proximal components will be able to mate with stem. all distal components, thus affording optimal flexibility. The Restoration™ Modular System components will be fabricated from Titanium (Ti6Al-4V) Alloy. The Cone and Broached body components as well as the Porous Stems will be offered with plasma spray or plasma spray and hydroxylapatite coatings.
The Restoration™ Modular System is a medical device designed for hip arthroplasty. The provided text outlines a 510(k) summary for a device modification to a 2-piece modular revision stem system. The study conducted to demonstrate its performance focuses on mechanical properties rather than AI/human reader performance.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly based on the mechanical strength and integrity required for femoral hip prostheses, as dictated by relevant international standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet or exceed defined performance values for mechanical strength of neck, proximal body, and distal stem regions. | "All tested components meet or exceed their defined performance values." |
| Demonstrate substantial equivalence in terms of safety and effectiveness to the legally marketed predicate components' mechanical properties. | "The testing demonstrates that, in terms of mechanical properties, the modified Restoration™ Modular Components are substantially equivalent to the legally marketed predicate components in terms of safety and effectiveness." |
Note: The document does not explicitly state numerical acceptance criteria, but rather general compliance with "defined performance values" and substantial equivalence to a predicate device.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document mentions "A series of fatigue tests were performed" and "Most severe case' components/assemblies were tested." However, it does not specify the exact number of samples (sample size) used for the test set.
- Data Provenance: The study was conducted by Howmedica Osteonics Corp., a US-based company. The nature of these tests (fatigue tests on physical components) implies a prospective generation of data in a laboratory setting rather than retrospective analysis of patient data. There is no information on country of origin of data in terms of patient data, as this is a mechanical test.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- Not Applicable: This study is a mechanical performance study of a prosthetic device, not a study evaluating diagnostic accuracy based on expert interpretation of medical images or clinical outcomes. Therefore, there were no human experts used to establish a ground truth for a test set in the traditional sense of a clinical or diagnostic study. The "ground truth" here is the physical performance of the device against engineering standards.
4. Adjudication Method for the Test Set
- Not Applicable: As this is a mechanical performance study, there was no adjudication method for a test set involving human interpretation or consensus. The performance is objectively measured against pre-defined engineering parameters and standards (ISO 7206-4 and ISO 7206-6).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: The document explicitly states, "A series of fatigue tests were performed to ensure the integrity of the Restoration™ Modular System." This is a mechanical engineering study, not an MRMC study comparing human readers with and without AI assistance. Therefore, no effect size for human readers improving with/without AI assistance is reported.
6. Standalone Performance Study (Algorithm only without human-in-the-loop)
- Not Applicable: This device is a physical medical implant, not a software algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop) performance" does not apply. The study focuses on the standalone mechanical performance of the device itself.
7. Type of Ground Truth Used for the Test Set
- Engineering Standards and Predicate Device Performance: The ground truth for the test set's performance was established by "defined performance criteria" derived from ISO 7206-4 and ISO 7206-6 (international standards for hip joint prostheses) and by comparison to the mechanical properties of a legally marketed predicate device (Restoration™ Modular (2 Piece Modular System) (K013106)).
8. Sample Size for the Training Set
- Not Applicable: This is a mechanical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used to train a model. The design and testing are based on engineering principles and material science.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As there is no training set for an AI model, there is no ground truth established for a training set. The device design itself is based on established engineering principles for biomechanics and material compatibility.
{0}------------------------------------------------
022549 page 1 of 2
510(k) Summary for the Restoration™ Modular System (Device Modification for the 2 Piece Modular Revision Stem System)
| Proprietary Name: | Restoration™ Modular System |
|---|---|
| Common Name: | Femoral Hip Prosthesis |
| Classification Name and Reference: | 21 CFR 888.3353Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis |
| Proposed Regulatory Class: | II |
| Device Product Code: | OR(87) LZO |
| For Information contact: | Jennifer A. Daudelin |
| Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 59 Route 17 | |
| Allendale, NJ 07401-1677 | |
| (201) 831-5379 | |
| Fax: (201) 831-6038 | |
| Date Summary Prepared: | July 31, 2002 |
SEP 23 2002#### Device Description
The 2 Piece Modular Hip Stem, hereby referred to as the Restoration™ Modular System, is a modular system comprised of a proximal body, distal stem, and locking bolt. These three individual components utilizing a modular junction are assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal This system is designed so that all proximal components will be able to mate with stem. all distal components, thus affording optimal flexibility.
The Restoration™ Modular System components will be fabricated from Titanium (Ti6Al-4V) Alloy. The Cone and Broached body components as well as the Porous Stems will be offered with plasma spray or plasma spray and hydroxylapatite coatings.
{1}------------------------------------------------
022549 page 2 of 2
Intended Use
This system is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.
Substantial Equivalence
The substantial equivalence of the Restoration™ Modular System is based upon equivalence in intended use, materials, and design to the following Howmedica Osteonics device: Restoration™ Modular (2 Piece Modular System) (K013106).
Performance Data
A series of fatigue tests were performed to ensure the integrity of the Restoration™ Modular System. Testing was performed to evaluate the strength of the neck, proximal body, and distal stem regions of the system. "Most severe case" components/assemblies were tested based upon the previous FEA results. Test methods were consistent with methods described in ISO 7206-4 and ISO 7206-6. The comparison of test results with defined performance criteria indicate that all tested components meet or exceed their defined performance values. In summary, the testing demonstrates that, in terms of mechanical properties, the modified Restoration™ Modular Components are substantially equivalent to the legally marketed predicate components in terms of safety and effectiveness.
{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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings and a head.
SEP 2 3 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jennifer A. Daudelin Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401-1677
Re: K022549
Trade Name: Restoration™ Modular System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or Porous uncemented prosthesis Regulatory Class:II Product Code: LZO Dated: July 31, 2002
Dear Ms. Daudelin:
Received: August 1, 2002
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 – Ms. Jennifer A. Daudelin
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,
R. 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}------------------------------------------------
022549
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
The Restoration™ Modular System is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
for Mark N. Mulhearn (Optional Format 1-2-96)
(Division Sign-Off)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
~ ^ ^(k ); Number_____________________________________________________________________________________________________________________________________________________________
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.