(260 days)
Not Found
No
The summary describes a mechanical implant (acetabular shell) and its manufacturing process. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
Explanation: The device is an acetabular shell system used in hip replacement, addressing conditions like degenerative joint disease and fractures, which fits the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is an acetabular shell system intended for surgical hip replacement, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a physical acetabular shell system, which is a hardware component for hip replacement surgery. The performance studies also describe physical testing of the device's material properties and mechanical performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for hip replacement, addressing various conditions affecting the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical characteristics and manufacturing process of an acetabular shell, a component of a hip replacement system. This is consistent with a surgical implant.
- Performance Studies: The performance studies listed are related to the mechanical properties and durability of the implant (shear testing, fatigue testing, abrasion resistance, etc.). These are typical tests for surgical implants, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
In summary, the Renovis Tesera Trabecular Technologies (T) Acetabular Shell System is a surgical implant intended for the treatment of hip joint conditions, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Renovis Tesera Trabecular Technology (T) Acetabular Shell System components are to be used with components of the Renovis A400 Surgical Hip Replacement System, and are indicated for patients suffering from the following:
- 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 Tesera Trabecular Technology (T) Acetabular Shell System is intended for cementless applications.
Product codes (comma separated list FDA assigned to the subject device)
LPH
Device Description
The Renovis Tesera Trabecular Technology (T3) Acetabular Shell System ("T" Acetabular Shell System") acetabular shells ("T" shells") are modifications of the Renovis A400 Surgical Hip Replacement System acetabular shells cleared through premarket notification K112897. This submission proposes the following design change: The proposed T shells will be manufactured from the same titanium alloy using an additive manufacturing process to fabricate the implant and porous structure concurrently, and have a thicker solid substrate and porous layer.
The T shells are to be used with polyethylene liners, femoral components, acetabular shell trials, and other system specific instruments originally cleared in the Renovis A400 Surgical Hip System (K112897). The T shell is available in multiple configurations (no hole shell; cluster hole shell) and sizes (44 - 66 mm diameter). The liners attach to the shells under impaction with a snap lock mechanism.
The T3 shells comply with the following material standards:
- ASTM F136-12(a) Standard Specification for Wrought Titanium-6Aluminum-. 4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
- ASTM F3001-13 Standard Specification for Additive Manufacturing Titanium-6 . Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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)
Bench testing was conducted including:
- ASTM F1044-05 (2011) Standard Test Method for Shear Testing of Calcium Phosphate . Coatings and Metallic Coatings
- . ASTM F1160-05 (2011) Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium/Phosphate Metallic Coatings
- ASTM F1147-05 (2011) Standard Test Method for Tension Testing of Calcium . Phosphate and Metallic Coatings
- . ASTM F1854-09 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants The results of ASTM F1854 testing demonstrate compliance with the requirements in 21 CFR 888.3358 for volume porosity, average pore size, and interconnecting porosity and porous coating thickness
- ASTM F1978-12 Standard Test Method for Measuring Abrasion Resistance of Metallic . Thermal Spray Coatings by Using the Taber Abraser
- Acetabular shell fatigue testing compared to a predicate device per Renovis protocol and . ASTM F1820-97 Standard Test Methods for Determining the Axial Disassembly Force of a Modular Acetabular Device
Sterilization and aging validation studies were conducted previously.
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
APR 1 1 2014
ORENOVIS
K132312 Page 1 of 3
Traditional 510(k) Summary as required by 21 CFR 807.92(a) K132312
| A ) Submitted by: | Renovis Surgical Technologies Inc.
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
Sharyn Orton, Ph.D. Consultant: MEDIcept, Inc. 200 Homer Ave Ashland, MA 01721
Date prepared: April 2, 2014
B) Device Name: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Common Name: Total Hip Arthroplasty - Acetabular Components
Renovis Tesera Trabecular Technology (T3) Acetabular Shell System Proprietary Name:
Device Class: Class II
21 CFR 888.3358 Regulation number:
Regulation name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
Product code: LPH
Classification panel: Orthopedic
- C) Predicates:
Renovis A400 Surgical Hip Replacement System (acetabular shells) K112897 Exactech Novation Crown Cup with InteGrip Acetabular Shell K102975
I
1
ORENOVIS
D) Device Description:
The Renovis Tesera Trabecular Technology (T3) Acetabular Shell System ("T" Acetabular Shell System") acetabular shells ("T" shells") are modifications of the Renovis A400 Surgical Hip Replacement System acetabular shells cleared through premarket notification K112897. This submission proposes the following design change: The proposed T shells will be manufactured from the same titanium alloy using an additive manufacturing process to fabricate the implant and porous structure concurrently, and have a thicker solid substrate and porous layer.
The T shells are to be used with polyethylene liners, femoral components, acetabular shell trials, and other system specific instruments originally cleared in the Renovis A400 Surgical Hip System (K112897). The T shell is available in multiple configurations (no hole shell; cluster hole shell) and sizes (44 - 66 mm diameter). The liners attach to the shells under impaction with a snap lock mechanism.
The T3 shells comply with the following material standards:
- ASTM F136-12(a) Standard Specification for Wrought Titanium-6Aluminum-. 4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
- ASTM F3001-13 Standard Specification for Additive Manufacturing Titanium-6 . Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion
E) Indications For Use:
The Renovis Tesera Trabecular Technology (T) Acetabular Shell System components are to be used with components of the Renovis A400 Surgical Hip Replacement System, and are indicated for patients suffering from the following:
-
- 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 Tesera Trabecular Technology (T) Acetabular Shell System is intended for cementless applications.
F) Substantial Equivalence Comparison and Discussion
The T Acetabular Shell System has similar Indications for Use, design, material, sizes and geometries, and compatible liners and femoral components as the K112897 A400 acetabular shells. The T Acetabular Shell System additive manufacturing process is similar to that of the K 102975 Exactech acetabular shells. The T shells have a thicker porous structure and solid substrate than the K112897 A400 acetabular shells. Differences between the Renovis T' shells and the predicate devices do not raise any new issues of safety or effectiveness.
2
ORENOVIS
G) Biocompatibility
The biocompatibility of Ti-6A1-4V EBM manufactured FDA cleared orthopedic implants has been demonstrated.
H) Performance Testing - Bench
The following performance tests were successfully conducted:
- ASTM F1044-05 (2011) Standard Test Method for Shear Testing of Calcium Phosphate . Coatings and Metallic Coatings
- . ASTM F1160-05 (2011) Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium/Phosphate Metallic Coatings
- ASTM F1147-05 (2011) Standard Test Method for Tension Testing of Calcium . Phosphate and Metallic Coatings
- . ASTM F1854-09 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants The results of ASTM F1854 testing demonstrate compliance with the requirements in 21 CFR 888.3358 for volume porosity, average pore size, and interconnecting porosity and
- porous coating thickness
- ASTM F1978-12 Standard Test Method for Measuring Abrasion Resistance of Metallic . Thermal Spray Coatings by Using the Taber Abraser
- Acetabular shell fatigue testing compared to a predicate device per Renovis protocol and . ASTM F1820-97 Standard Test Methods for Determining the Axial Disassembly Force of a Modular Acetabular Device
Sterilization and aging validation studies were conducted previously.
Conclusion
The similarity in Indications for Use, sizes, geometries and technology and the performance testing and biocompatibility data submitted support that the Renovis T Acetabular Shell System is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-GKA99 Silver Spring MI) 20993-0002
April 11, 2014
Renovis Surgical Technologies Incorporated % Dr. Sharyn Orton Senior Consultant MEDIcept. Incorporated 200 Homer Avenue Ashland, Massachusetts 01721
Re: K132312
Trade/Device Name: Renovis Tesera Trabecular Technology (T3) Acetabular Shell 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: LPH Dated: March 12, 2014 Received: March 13, 2014
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
4
Page 2 - Dr. Sharyn Orton
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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/McdicalDevices/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 vours.
Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number (if known): K132312
Device Name: Renovis Tesera Trabecular Technologies (T) Acetabular Shell System
Indications for Use:
The Renovis Tesera Trabecular Technologies (T) Acetabular Shell System components are to be used with components of the Renovis A400 Surgical Hip Replacement System, and are 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 5. Revision procedures where other treatment or devices have failed.
The Renovis Tesera Trabecular Technologies (T) Acetabular Shell System is intended for cementless applications.
Prescription Use AND/OR (21 CFR 801 Subpart D)
Over-the-Counter Use (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)
Elizabet情診所rank -S
Division of Orthopedic Devices
Renovis T Acetabular Shell System
Traditional 510(k) Premarket Notification 6-1