The Restoration Acetabular Wedge Augments are intended for use as an alternative to structural allograft in cases of superior and superior/posterior segmental acetabular deficiencies.

General Indications for Total Hip Replacement Components:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic 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.

Indications Specific to the Acetabular Wedges:

As an alternative to structural allograft in cases of superior and superior/posterior . segmental acetabular deficiencies.
Acetabular Augments are intended for cementless use only to the bone interface; and 2) are affixed to the mating cup using bone cement

Device Description

Restoration Acetabular Wedge Augments provide options to address a wide range of bone deficiencies encountered in acetabular revision. The augments provide support for the shell in the acetabulum with superior and/or posterior defects. The augments are offered in various geometries and sizes to address wide defect ranges. The augments are made of commercially pure titanium porous sintered foam. The Restoration Acetabular Wedge Augments can be used with Restoration ADM, Secur-Fit, Trident, and Tritanium uncemented shells. The Restoration Acetabular Wedge Augments can be used with Trident all-polyethylene cemented cups

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Restoration Acetabular Wedge Augments." This submission is for a medical device that substitutes for allografts in hip reconstructive surgeries. The crucial information regarding acceptance criteria and study details is presented below, extracting from the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The submission relies on a demonstration of substantial equivalence to predicate devices rather than meeting specific performance criteria in a clinical setting. Therefore, the "acceptance criteria" are related to mechanical and material properties that demonstrate comparable safety and efficacy to existing legally marketed devices.

Acceptance Criteria (Demonstrated Equivalence)	Reported Device Performance
Mechanical Properties:- Tensile strength- Compression strength- Construct fatigue testing (augment/shell)- Static compression strength post-fatigue- Abrasion post-fatigue	Performed mechanical testing according to "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Cement (28 April 1994)".- "There was no affect on mechanical morphological properties based on fatigue loading."- Testing demonstrated substantial equivalence to currently cleared devices.
Material Properties (CP Titanium porous sintered foam):- Volume porosity- Average pore size- Mean intercept length- Grain size- Morphological properties post-fatigue	Determined these parameters for the CP Titanium porous sintered foam.- "There was no affect on mechanical morphological properties based on fatigue loading."- Testing demonstrated substantial equivalence to currently cleared devices.
Intended Use Equivalence:- As an alternative to structural allograft in cases of superior and superior/posterior segmental acetabular deficiencies.- Cementless use to bone interface, affixed to mating cup using bone cement.	Device comparison showed that the proposed device is substantially equivalent in intended use to the predicate devices (Zimmer Trabecular Metal Augments K061067 and Osteonics Acetabular Wedge System K971422).
Material Equivalence:- Made of commercially pure titanium porous sintered foam.	Device comparison showed that the proposed device is substantially equivalent in materials to the predicate devices.
Performance Characteristics Equivalence:- Provides support for the shell in the acetabulum with superior and/or posterior defects.- Offered in various geometries and sizes.- Can be used with Restoration ADM, Secur-Fit, Trident, and Tritanium uncemented shells, and Trident all-polyethylene cemented cups.	Device comparison showed that the proposed device is substantially equivalent in performance characteristics to the predicate devices. Mechanical and material testing supported this equivalence by demonstrating no adverse effects from fatigue loading and characterizing key properties of the porous foam.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document explicitly states: "Non-Clinical laboratory testing was performed..." and "Clinical testing was not required for this submission." This indicates that no human test set data was used. The testing involved mechanical and material analyses of the device itself.
Data Provenance: Not applicable as no human data was used. The non-clinical testing would have been conducted in a laboratory setting, likely in the country of origin of the manufacturer (USA, given the address).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. No human test set requiring ground truth establishment by experts was conducted. The evaluation was based on non-clinical mechanical and material properties.

4. Adjudication Method for the Test Set

Not applicable. No human test set requiring adjudication was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. Clinical testing was explicitly stated as "not required for this submission."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical implant, not a software algorithm.

7. Type of Ground Truth Used

Not applicable as no human data was used. The "ground truth" in this context would be the established engineering standards and material properties, which are used to evaluate the device against predicate devices through non-clinical testing.

8. Sample Size for the Training Set

Not applicable. This device is a physical implant and no AI/machine learning training set was used.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

Summary

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K102019

MAR - 3 2011

510(k) Summary

Sponsor	Howmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430
Contact Person	Karen AriemmaProject Manager, Regulatory Affairs/Regulatory ComplianceHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5718
Date Prepared:	February 14, 2011
Proprietary Name:	Restoration Acetabular Wedge Augments
Common Name:	Acetabular Bone Augments
Classification Name:	21 CFR §888.3358Prosthesis, hip, semi-constrained, metal/polymer, porousuncemented

Legally Marketed Device to Which Substantial Equivalence is Claimed:

Zimmer Trabecular Metal Augments K061067 and the Osteonics Acetabular Wedge System K971422.

Device Description:

Intended Use:

The Restoration Acetabular Wedge Augments are intended for use as an alternative to structural allograft in cases of superior and superior/posterior segmental acetabular deficiencies.

Indications:

General Indications for Total Hip Replacement Components:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic 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 .

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p. 2/2

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.
K102019

Indications Specific to the Acetabular Wedges:

As an alternative to structural allograft in cases of superior and superior/posterior segmental 0 acetabular deficiencies.
Acetabular Augments are intended for cementless use only to the bone interface; and 2) are affixed to the mating cup using bone cement

Summary of Technologies: Device comparison showed that the proposed device is substantially equivalent in intended, use, materials and performance characteristics to the predicate device.

Non-Clinical Testing: Non-clinical laboratory testing was performed for the CP Titanium porous sintered foam to determine substantial equivalence. Non-clinical testing was provided as outlined in the FDA Guidance Document entitled "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Cement (28 April 1994)". The following mechanical testing was performed: tensile, compression, and construct fatigue testing of the augment/shell construct. The following parameters of the CP Titanium porous sintered foam were determined: volume porosity, average pore size, mean intercept length and grain size. In addition, static compression strength, abrasion and morphological properties were determined post fatigue testing. There was no affect on mechanical morphological properties based on fatigue loading. The testing demonstrated that the Restoration Acetabular Wedge Augments are substantially equivalent to devices currently cleared for market.

Clinical Testing: Clinical testing was not required for this submission.

Conclusion: The Restoration Acetabular Wedge Augments are substantially equivalent to the predicate devices identified in this premarket notification.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR - 3 2011

Howmedica Osteonics Corp. % Ms. Karen Ariemma Project Manager, Regulatory Affairs and Regulatory Compliance 325 Corporate Drive Mahwah, New Jersey 07430

Re: K102019

Trade/Device Name: Restoration Acetabular Wedge Augments 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: February 14, 2011 Received: February 16, 2011

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, Or to 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 1.0 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 contractly and 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

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Page 2 - Ms. Karen Ariemma

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 on modical device-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 election is 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 305%m lase 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

A. B. n h
for

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

102019

510(k) Number (if known): K102019

Device Name: Restoration Acetabular Wedge Augments

Indications for Use:

The indications for use of the Restoration Acetabular Wedge Augments:

General Indications for Total Hip Replacement Components:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic 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.

Indications Specific to the Acetabular Wedges:

As an alternative to structural allograft in cases of superior and superior/posterior . segmental acetabular deficiencies.
Acetabular Augments are intended for cementless use only to the bone interface; and 2) are affixed to the mating cup using bone cement

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (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

for M.melkerson

Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102019

Regulation Number and Section

§ 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.