(111 days)
The RIGI-FIX™ Hip Stem System is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to femoral hip stem revisions.
The RIGI-FIX™ Hip Stem System is a non-cemented acetabular cup system with a complete assortment of neutral and 10° hooded poly inserts as well as acetabular screws and screw hole covers (screw hole occluders).
The provided text is a 510(k) Summary and FDA clearance letter for the RIGI-FIX™ Hip Stem System. This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting a detailed study with specific acceptance criteria and performance metrics for the device itself.
Therefore, most of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance is not available in the provided document.
Here's a breakdown of what can be extracted:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a specific clinical or diagnostic outcome. The acceptance is based on "substantial equivalence" to legally marketed predicate devices.
- Reported Device Performance: "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading." No specific values or criteria are provided other than the general statement of equivalence and sufficiency for in vivo loading.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The document describes biomechanical testing, not a clinical or diagnostic study with a test set of data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No ground truth establishment for a diagnostic test set is mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or human interpretation is discussed.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a medical implant, not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a medical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this device's performance relies on the biomechanical properties meeting established engineering standards and being equivalent to predicate devices.
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The sample size for the training set
- Not Applicable. No training set for an algorithm is discussed.
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How the ground truth for the training set was established
- Not Applicable. No training set is discussed.
Summary based on the provided document:
The RIGI-FIX™ Hip Stem System gained market clearance based on substantial equivalence to predicate devices (BIOMET TAPERLOC Femoral Stem, K921301 and K043537). The performance demonstration relies on biomechanical tests showing equivalence to other similar implants and sufficiency for in vivo loading. Specific quantitative acceptance criteria or detailed study results beyond this general statement are not included in the summary provided. This type of 510(k) submission generally focuses on engineering and material equivalence for an implant rather than diagnostic accuracy studies typically associated with AI or imaging devices.
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607210| (pg 1/1)
510(k) Summary of Safety and Effectiveness
[in accordance with SMDA of 1990, 21 CFR 807.92(c)]
- Mr. Mohan Emmanuel, President Contact: Implants International, Ltd., NOV 1 9 2007 71 Jay Avenue Teeside Industrial Est. Thornby-On-Tees United Kingdom T5179Lz Telephone: 011-44-78433-80023 Email: mohan.emmanuel@implantsinternational.com RIGI-FIX™ Hip Stem System Trade name: Femoral Hip Stem Common name: Hip joint metal/polymer/metal semi-constrained porous-coated Classification uncemented prosthesis name: Hip joint metal/polymer/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Requlation 21 CFR 888.3353 - Class II, Orthopedic Device Panel 87 number: MEH, LPH Product Code: The RIGI-FIX™ Hip Stem System is a non-cemented acetabular cup Device system with a complete assortment of neutral and 10° hooded poly Description and inserts as well as acetabular screws and screw hole covers (screw Characteristics: hole occluders). The RIGI-FIX™ Hip Stem System is equivalent to other legally Equivalence: marketed acetabular cup systems in design, materials and intended use. Equivalent devices include the: BIOMET TAPERLOC Femoral Stem (K921301 S/E 2/16/94 and K043537 S/E 1/14/05) The RIGI-FIX™ Hip Stern System is intended for uncemented use for Indications: all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to femoral hip stem revisions. Biomechanical tests have been performed. The test results were Performance equivalent to other similar implants and are sufficient for in vivo data: loading.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Implants International, Ltd. % Mr. Mohan Emmanuel Chief Executive 71 Jay Avenue, Teesside Industrial Estate Thornaby-on-Tees. Cleveland. TS17 9LZ UK
NOV 1 9 2007
Re: K072101 Trade Name: RIGI-FIX™ Hip Stem 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: MEH, LPH Dated: October 18, 2007 Received: October 22, 2007
Dear Mr. Emmanuel:
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 (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.
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Page 2 - Mr. Mohan Emmanuel
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 the reporting 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 vours.
barbare buchns
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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510(k) Number: Kon2 101 (pg)/1)
Device Name(s):
RIGI-FIX™ Hip Stem System
Indications for Use:
The RIGI-FIX™ Hip Stem System is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis. fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to femoral hip stem revisions.
Prescription Use X - -
AND/OR
Over-The-Counter-Use
(21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tarbere Brienn
Division of General, Restorative, and Neurological Devices
510(k) Number_ kn +20
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§ 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.