(87 days)
The Restoration™ ADM is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 22.2 and 28 mm diameter femoral heads.
The indications for use of total hip replacement prostheses include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed;
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- Dislocation risks
This acetabular cup is intended for cementless use only.
The Restoration™ Anatomic Dual Mobility (ADM) System consists of an acetabular cup and an acetabular insert. The Restoration™ ADM insert retains a femoral head. The outer diameter of the insert articulates on the inner surface of the polished metal acetabular cup. The polyethylene insert therefore functions as a bipolar head as there are two articulating surfaces.
The Restoration™ ADM Acetabular Cup has a highly polished inner surface to help reduce wear between the cup and the insert and an anatomical shaped rim to limit cup impingement with the stem or the psoas muscle. The Restoration™ ADM Acetabular Cup is manufactured from wrought Cobalt Chromium alloy with a Commercially Pure Titanium and Hydroxylapatite coating.
The provided document, K072020, is a 510(k) summary for the Restoration™ ADM System, an artificial hip replacement component. It aims to establish substantial equivalence to predicate devices and does not describe a study involving acceptance criteria and device performance in the way a clinical trial or a validation study for an AI/ML device would.
Therefore, most of the requested information cannot be extracted from this document, as the submission appears to rely on established equivalence to existing devices rather than new performance studies with specific acceptance criteria in a clinical context.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. The document does not specify performance metrics or acceptance criteria for the Restoration™ ADM System itself, nor does it present the results of a study demonstrating its performance against such criteria. The submission relies on demonstrating substantial equivalence to predicate devices, implying that their established performance is sufficient.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. No test set or clinical study to establish performance is described. The submission focuses on device characteristics and indications for use, comparing them to legally marketed predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. There is no mention of a test set requiring ground truth established by experts.
4. Adjudication Method for the Test Set:
Not applicable. No test set is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a medical device (hip implant), not an AI/ML diagnostic or image analysis system that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used:
Not applicable. No performance study requiring ground truth is described.
8. Sample Size for the Training Set:
Not applicable. No training set for an algorithm is relevant to this device submission.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set for an algorithm is relevant to this device submission.
Summary based on the document:
The 510(k) K072020 for the Restoration™ ADM System focuses on demonstrating substantial equivalence to predicate devices (Trident® Acetabular System, Biomet Tri-Polar System, Plus Orthopaedics Ag Polarcup Dual Mobility System and UHR Bipolar System) regarding its intended use, design, materials, and operational principles. This is a regulatory pathway that typically does not require new clinical performance studies or the establishment of specific acceptance criteria beyond demonstrating that the new device is as safe and effective as a legally marketed device.
The FDA's letter (on page 3 of the document) confirms that they have reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. This determination allows the device to be marketed, subject to general controls provisions.
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1072020
OCT 1 8 2007
510(k) Summary of Safety and Effectiveness
| Proprietary Name: | Restoration™ ADM System |
|---|---|
| Common Name: | Artificial Hip Replacement Components - Acetabular |
| Classification Name and Reference: | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, 21 CFR §888.3353 |
| Proposed Regulatory Class: | Class II |
| Product Codes: | 87 MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium- phosphate |
| For Information contact: | Karen Ariemma Senior Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5718 Fax: (201) 831-6038 |
| Date Prepared: | October 17, 2007 |
Description:
The Restoration™ Anatomic Dual Mobility (ADM) System consists of an acetabular cup and an acetabular insert. The Restoration™ ADM insert retains a femoral head. The outer diameter of the insert articulates on the inner surface of the polished metal acetabular cup. The polyethylene insert therefore functions as a bipolar head as there are two articulating surfaces.
The Restoration™ ADM Acetabular Cup has a highly polished inner surface to help reduce wear between the cup and the insert and an anatomical shaped rim to limit cup impingement with the stem or the psoas muscle. The Restoration™ ADM Acetabular Cup is manufactured from wrought Cobalt Chromium alloy with a Commercially Pure Titanium and Hydroxylapatite coating.
Intended Use
The Restoration™ ADM is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is
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intended to be used only with any currently available Howmedica Osteonics 22.2 and 28 mm diameter femoral heads.
Indications:
The indications for use of total hip replacement prostheses include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis:
- Rheumatoid arthritis; 2)
-
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; 4)
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal ર) femur with head involvement that are unmanageable using other techniques.
-
- Dislocation risks
This acetabular cup is intended for cementless use only.
Substantial Equivalence:
The Restoration™ ADM Acetabular System is substantially equivalent to other commercially available acetabular systems in regards to intended use, design, materials, and operational principles. The following devices are examples of predicate systems: Trident® Acetabular System, Biomet Tri-Polar System, Plus Orthopaedics Ag Polarcup Dual Mobility System -and UHR Bipolar System.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2007
Howmedica Osteonics Corp. % Ms. Karen Ariemma Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K072020
Trade/Device Name: Restoration Anatomic™ Dual Mobility (ADM) System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code(s): MEH, LZO Dated: July 20, 2007 Received: July 23, 2007
Dear Ms. Ariemma:
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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic
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Page 2 - Ms. Karen Ariemma
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely, yours,
Clarlara Buchn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K072020
Device Name: Restoration™ ADM System
Indications for Use:
The indications for use of the total hip replacement prostheses include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis;
- Rheumatoid arthritis 2)
-
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; 4)
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal 2) femur with head involvement that are unmanageable using other techniques.
-
- Dislocation risks
This acetabular cup is intended for cementless use only.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)
Solace Buetm
Page 1 of 1
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(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.