(140 days)
Not Found
No
The document describes a hip replacement system and its components, focusing on materials, dimensions, and mechanical testing. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is a hip replacement system, which clearly falls under the definition of a therapeutic device as it is used to treat or alleviate a medical condition (degenerative joint disease, rheumatoid arthritis, fractures, etc.).
No
The device description clearly states that it is a "Surgical Hip Replacement System," an implantable prosthesis designed to replace a hip joint. Its intended use is for patients suffering from various degenerative conditions or fractures, not to diagnose them.
No
The device description explicitly states that the subject of the application are "Renovis 4.5mm femoral stems (and a 5.25 mm broach)" and lists material standards for physical implants and instruments. This indicates the device is a physical implant system, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a hip joint in patients with various conditions affecting the hip. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details surgical implants (femoral stems) made of various metal alloys. This aligns with a surgical prosthesis, not a device used to examine specimens from the human body.
- Performance Studies: The performance studies mentioned are related to the mechanical properties of the implant (fatigue testing, coating characterization), which are relevant for a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the Renovis Surgical Hip Replacement System is a surgical implant, not an IVD.
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 used with the Renovis Cemented Hip Stem.
Product codes (comma separated list FDA assigned to the subject device)
OQI, LZO, OQG, LPH
Device Description
The subject of this application are Renovis 4.5mm femoral stems (and a 5.25 mm broach) which are an expansion of the FDA cleared Renovis A400 Surgical Hip Joint Replacement Prosthesis (K112897) which is now known as the Renovis Surgical Hip Replacement System. The 4.5mm and 5.25mm femoral stems are the same material, the same configuration and will be offered in the same standard and lateralized offsets, as are the FDA cleared Renovis A400 femoral stems.
In addition, this application includes an update of Letter-to-File expansions and changes to the Renovis Surgical Hip Replacement System.
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 F1537-11 Standard Specification for Wrought Cobalt-28Chromium-● 6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
- ASTM A276-13a Standard Specification for Stainless Steel Bars and Shapes
- ASTM A240-14 Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Hip joint, proximal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 4.5mm and 5.25mm femoral stems have been assessed for risk per Renovis SOP and were either accepted into previous static/fatigue testing, or successfully completed fatigue testing per the following standard:
- 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
Additionally, coating characterization of the 4.5mm and 5.25mm femoral stems was conducted.
The results of assessment and performance testing under design controls support that the 4.5 mm and 5.25 mm femoral stems do not raise new issues of safety and effectiveness.
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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Renovis Surgical Technologies, Incorporated % Sharyn Orton, Ph.D. Senior Consultant MEDIcept Incorporated 200 Homer Avenue Ashland, Massachusetts 01721
May 11, 2013
Re: K143647
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: April 10, 2015 Received: April 13, 2015
Dear Dr. 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
1
Page 2 - Sharyn Orton, Ph.D.
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
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) K143647
Device Name Renovis Surgical Hip Replacement System
Indications for Use (Describe) 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 used with the Renovis Cemented Hip Stem.
Type of Use (Select one or both, as applicable)
X 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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3
Traditional 510(k) Summary as required by 21 CFR 807.92(a) K143647
| 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) Common name: | Prosthesis, Hip Revision System |
| Proprietary Name: | Renovis Surgical Hip Replacement System |
| Device Class: | Class II |
| Regulations and
Classification names: | 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-
constrained cemented or nonporous uncemented prosthesis
21 CFR 888.3358 Hip joint metal/polymer/metal semi-constrained
porous-coated uncemented prosthesis |
| Product codes: | OQI
LZO
OQG
LPH |
| Classification panel: | Orthopedic |
| C) Predicates: | K112897 Renovis A400 Surgical Hip Joint Replacement
Prosthesis (femoral stems) |
| D) Date Prepared: | April 29, 2015 |
E) Device Description:
The subject of this application are Renovis 4.5mm femoral stems (and a 5.25 mm broach) which are an expansion of the FDA cleared Renovis A400 Surgical Hip Joint
4
Replacement Prosthesis (K112897) which is now known as the Renovis Surgical Hip Replacement System. The 4.5mm and 5.25mm femoral stems are the same material, the same configuration and will be offered in the same standard and lateralized offsets, as are the FDA cleared Renovis A400 femoral stems.
In addition, this application includes an update of Letter-to-File expansions and changes to the Renovis Surgical Hip Replacement System.
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 F1537-11 Standard Specification for Wrought Cobalt-28Chromium-● 6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
- ASTM A276-13a Standard Specification for Stainless Steel Bars and Shapes
- ASTM A240-14 Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications
E) 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.
F) Substantial Equivalence Comparison and Discussion
The Renovis 4.5mm and 5.25mm femoral stems have the same Indications for Use, are manufactured from the same material, have the same configuration, will use the same offset options, and are provided sterile like the cleared Renovis A400 femoral stems. The difference is that they are offered in a smaller size and there is a change in the plasma spray manufacturing. The results of assessment and performance testing under design controls support that the 4.5 mm and 5.25 mm femoral stems do not raise new issues of safety and effectiveness.
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G) Non-clinical Testing
The 4.5mm and 5.25mm femoral stems have been assessed for risk per Renovis SOP and were either accepted into previous static/fatigue testing, or successfully completed fatigue testing per the following standard:
- . 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
Additionally, coating characterization of the 4.5mm and 5.25mm femoral stems was conducted.
There is no change in biocompatibility, sterilization, packaging or shelf life.
Conclusion
The Renovis 4.5mm and 5.25mm femoral stems are substantially equivalent to the FDA cleared Renovis A400 femoral stems, and are expected to perform per their Indications for Use as evidenced by assessment and/or bench testing under Design Controls.
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
- 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. ●