(227 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of the acetabular wedge augments, with no mention of AI or ML.
Yes.
The device is an implant for total hip replacement, aiming to alleviate pain and restore joint function in patients with disabling hip diseases, which aligns with the definition of a therapeutic device.
No
Explanation: The device is an implantable medical device (acetabular wedge augments) used in total hip replacement surgeries to address bone deficiencies, not to diagnose medical conditions.
No
The device description clearly states the device is made of "commercially pure titanium porous sintered foam" and is a physical implant (augments) used in hip replacement surgery. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Restoration Acetabular Wedge Augments are implants intended for surgical use to address bone deficiencies in the acetabulum during hip replacement or revision surgery. They are physical components used within the body, not tests performed on samples outside the body.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.
Therefore, the Restoration Acetabular Wedge Augments fall under the category of a surgical implant or prosthetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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
Product codes (comma separated list FDA assigned to the subject device)
LPH
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acetabulum / hip
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: 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.
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
MAR - 3 2011
510(k) Summary
| Sponsor | Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Karen Ariemma
Project Manager, Regulatory Affairs/Regulatory Compliance
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430
Phone: (201) 831-5718 |
| Date Prepared: | February 14, 2011 |
| Proprietary Name: | Restoration Acetabular Wedge Augments |
| Common Name: | Acetabular Bone Augments |
| Classification Name: | 21 CFR §888.3358
Prosthesis, hip, semi-constrained, metal/polymer, porous
uncemented |
Legally Marketed Device to Which Substantial Equivalence is Claimed:
Zimmer Trabecular Metal Augments K061067 and the Osteonics Acetabular Wedge System K971422.
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
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 .
1
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.
2
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
3
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
4
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