(174 days)
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No
The document describes a mechanical hip replacement system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are focused on mechanical and sterilization properties.
Yes
The device is a component of a hip replacement system, indicated for various medical conditions like degenerative joint disease and rheumatoid arthritis, which are treated to alleviate symptoms and restore function.
No
The device is a surgical hip replacement system, used for treatment (replacement of a hip joint), not for diagnosis.
No
The device description clearly states it is a hip replacement system including femoral stems, neck trials, X-ray templates, implants, and instruments, which are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that this device is a hip replacement system, specifically focusing on femoral stems and related components used in surgical procedures.
- Intended Use: The intended use describes the conditions for which the hip replacement system is indicated, all of which involve replacing or repairing the hip joint within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, laboratory testing, or providing diagnostic information based on samples taken from the body.
This device is an implantable medical device used in surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Renovis Surgical Hip Replacement System is indicated for patients suffering from:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
- Rheumatoid arthritis;
- Correction of functional deformity;
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques: and
- Revision procedures where other treatment or devices have failed.
The Renovis A400 Hip System is intended for cementless applications unless used with the Renovis Cemented Hip Stem. The Renovis Surgical Porous Coated Acetabular Shell System is intended for cementless applications.
The Cemented Hip Stem is intended for cemented applications.
The Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System is intended for cementless applications.
The Bipolar Head is for use in conjunction with Renovis femoral heads and femoral stems.
Bipolar outer heads are not for use with acetabular shells and liners.
Product codes (comma separated list FDA assigned to the subject device)
OQG, OQI, LPH, LZO
Device Description
The subject of this application is Renovis Extended Lateral Offset Femoral Stems which are an expansion of the FDA cleared Renovis Surgical Hip Replacement System. Extended Lateral Offset Femoral Stems are provided in a variety of sizes to fit patient need. This application also includes a new device specific neck trial and X-ray template, and additional implants and instruments.
The Extended Lateral Offset Femoral Stems are manufactured from the same material as other FDA cleared Renovis femoral stems. The instruments are manufactured from the same material as other instruments included in FDA cleared submissions.
Renovis implants and instruments comply with the following material standards:
- ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-. 4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
- ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-● Hardening Stainless Steel Bars and Shapes
- ASTM A276-17 Standard Specification for Stainless Steel Bars and Shapes ●
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip Joint
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Renovis successfully completed the following performance tests:
- ISO 7206-4: 2010 Implants for surgery - Partial and total hip-joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components
- ISO 7206-6: 2013 Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
- ANSI/AAMI/ISO 11137-1:2006 (R2010) and A1:2013 Sterilization of health care ● products - Radiation and Sterilization of health care products
- ANSI/AAMI/ISO 11137-2:2013 Radiation Part 2: Establishing the sterilization dose ●
Pyrogenicity Testing:
Bacterial endotoxin testing was conducted in compliance with ANSI/AAMI ST72:2011(R)2016 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing, and endotoxin limits are in compliance with ANSVAAMI ST72:2011(R)2016.
Biocompatibility, sterilization, and shelf life:
There is no change in material, sterilization method or shelf-life from the predicate devices.
Key results: The results of performance testing support that the Extended Lateral Offset Femoral Stems do not raise new issues of safety and effectiveness and are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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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.
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November 16, 2017
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
Renovis Surgical Technologies % Sharyn Orton Senior Consultant MEDIcept, Inc 200 Homer Ave Ashland, Massachusetts 01721
Re: K171543
Trade/Device Name: Renovis Surgical Hip Replacement System 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: OQG, OQI, LPH, LZO Dated: October 12, 2017 Received: October 13, 2017
Dear Sharyn Orton:
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. Please note: CDRH does not evaluate information related to contract liability 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 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 of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171543
Device Name Renovis Surgical Hip Replacement System Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
Indications for Use (Describe)
The Renovis Surgical Hip Replacement System is indicated for patients suffering from:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
-
Rheumatoid arthritis;
-
Correction of functional deformity;
-
Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement. unmanageable using other techniques: and
-
Revision procedures where other treatment or devices have failed.
The Renovis A400 Hip System is intended for cementless applications unless used with the Renovis Cemented Hip Stem. The Renovis Surgical Porous Coated Acetabular Shell System is intended for cementless applications.
The Cemented Hip Stem is intended for cemented applications.
The Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System is intended for cementless applications.
The Bipolar Head is for use in conjunction with Renovis femoral heads and femoral stems.
Bipolar outer heads are not for use with acetabular shells and liners.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden. to:
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ORENOVIS
Traditional 510(k) Summary as required by 21 CFR 807.92(a) K171543
| A ) Submitted by: | Renovis Surgical Technologies
1901 W. Lugonia Ave, Ste 340
Redlands, CA 92374
Phone: 909-557-2360
Fax: 909-307-8571 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Anthony DeBenedictis
Vice President of Quality Assurance |
| Consultant: | Sharyn Orton, Ph.D.
MEDIcept, Inc.
200 Homer Ave
Ashland, MA 01721 |
| B) Classification Name: | Prosthesis, Hip Revision System |
| Proprietary Name: | Renovis Surgical Hip Replacement System |
| Device Class: | Class II |
| Regulations | 21 CFR 888.3358 Hip joint metal/polymer/metal semi-
constrained porous-coated uncemented prosthesis
21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-
constrained cemented or nonporous uncemented prosthesis |
| and Product Codes: | OQG, OQI, LPH, LZO |
| Classification panel: | Orthopedic |
| C) Predicate: | K112897 Renovis A400 Surgical Hip Joint Replacement
Prosthesis (Tapered Lateral Offset Femoral Stems)
K141676 Renovis Surgical Porous Acetabular Cup System
K143647 Renovis Surgical Hip Replacement System |
| D) Date Prepared: | November 13, 2017 |
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E) Device Description:
The subject of this application is Renovis Extended Lateral Offset Femoral Stems which are an expansion of the FDA cleared Renovis Surgical Hip Replacement System. Extended Lateral Offset Femoral Stems are provided in a variety of sizes to fit patient need. This application also includes a new device specific neck trial and X-ray template, and additional implants and instruments.
The Extended Lateral Offset Femoral Stems are manufactured from the same material as other FDA cleared Renovis femoral stems. The instruments are manufactured from the same material as other instruments included in FDA cleared submissions.
Renovis implants and instruments comply with the following material standards:
- ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-. 4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
- ASTM A564-13 Standard Specification for Hot-Rolled and Cold-Finished Age-● Hardening Stainless Steel Bars and Shapes
- ASTM A276-17 Standard Specification for Stainless Steel Bars and Shapes ●
E) Intended Use/Indications For Use:
The Renovis Surgical Hip Replacement System is indicated for patients suffering from: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
-
- Rheumatoid arthritis:
-
- Correction of functional deformity;
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
-
- Revision procedures where other treatment or devices have failed.
The Renovis A400 Hip System is intended for cementless applications unless used with the Renovis Cemented Hip Stem.
- Revision procedures where other treatment or devices have failed.
The Renovis Surgical Porous Coated Acetabular Shell System is intended for cementless applications.
The Cemented Hip Stem is intended for cemented applications.
The Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System is intended for cementless applications.
The Bipolar Head is for use in conjunction with Renovis femoral heads and femoral stems.
Bipolar outer heads are not for use with acetabular shells and liners.
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F) Substantial Equivalence Comparison and Discussion
Additional predicate devices include Renovis FDA cleared Tapered Lateral Offset Femoral Stems in K141676 and K143647. The Extended Lateral Offset Femoral Stems are manufactured in a similar way, from the same material; have the same sizes; same sterilization; and same shelf-life as the Tapered Lateral Offset Femoral Stems in FDA cleared K112897, K141676 and K143647.
The difference between the predicate and new femoral stems is the offering of an extended lateral offset. The results of performance testing support that the Extended Lateral Offset Femoral Stems do not raise new issues of safety and effectiveness and are substantially equivalent to the predicate devices.
G) Performance Testing - Bench
Renovis successfully completed the following performance tests:
- ISO 7206-4: 2010 Implants for surgery - Partial and total hip-joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components
- ISO 7206-6: 2013 Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
- ANSI/AAMI/ISO 11137-1:2006 (R2010) and A1:2013 Sterilization of health care ● products - Radiation and Sterilization of health care products
- ANSI/AAMI/ISO 11137-2:2013 Radiation Part 2: Establishing the sterilization dose ●
Pyrogenicity Testing
Bacterial endotoxin testing was conducted in compliance with ANSI/AAMI ST72:2011(R)2016 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing, and endotoxin limits are in compliance with ANSVAAMI ST72:2011(R)2016.
Biocompatibility, sterilization, and shelf life
There is no change in material, sterilization method or shelf-life from the predicate devices.
H) Additional Consensus Standards and Guidance
- ASTM F565-04 (reapproved 2013) Standard Practice for Care and Handling of ● Orthopedic Implants and Instruments
- ASTM F983-86 (reapproved 2013) Standard Practice for Permanent Marking of Orthopaedic Implant Components
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- Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained ● Cemented or Uncemented Prosthesis; guidance for Industry and FDA" dated April 30, 2002
- Non-clinical Information for Femoral Stem Prostheses" dated September 17, 2007. ●
- Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Guidance for Industry and Food and Drug Administration Staff," January 2016, updated March 16, 2016
Conclusion
The Renovis Extended Lateral Offset Femoral Stems are substantially equivalent to the FDA cleared Renovis Tapered Lateral Offset Femoral Stems.