(164 days)
Not Found
No
The 510(k) summary describes a mechanical implant system and the performance studies are bench tests related to material properties and mechanical integrity. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is a total hip arthroplasty system, which is used to replace articulating surfaces of the hip joint to alleviate pain and restore function, hence, it is a therapeutic device.
No
Explanation: The device is a total hip arthroplasty system intended for replacing hip joint components in various orthopedic conditions, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the system includes both femoral and acetabular components, which are physical implants. The performance studies also detail bench testing of these physical components (femoral stem, femoral neck, screws, etc.). This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Responsive Orthopedics Total Hip Arthroplasty System is a "total hip system that allows for the restoration of alignment, stability and range of motion, and alleviates pain, by replacing the articulating surfaces of the hip joint." This is a surgical implant, not a device that analyzes biological samples.
- Intended Use: The intended use describes the conditions for which the hip replacement is indicated (osteoarthritis, rheumatoid arthritis, etc.). These are clinical conditions treated by replacing a joint, not by analyzing samples.
- Performance Studies: The performance studies listed are bench tests related to the mechanical properties and durability of the implant (fatigue testing, disassembly testing, wear, etc.). These are typical tests for surgical implants, not for IVDs which would involve analytical and clinical performance studies on patient samples.
The information provided describes a surgical implant used to replace a damaged hip joint, which is a completely different category of medical device than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Responsive Orthopedics Total Hip Arthroplasty System is indicated for cementless use only in the following cases:
- · Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- · Rheumatoid arthritis;
- · Correction of functional deformity;
- · Revision procedures where other treatments or devices have failed; and
- Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The Responsive Orthopedics Total Hip Arthroplasty System Acetabular screws are indicated for supplemental fixation of Responsive Orthopedics Acetabular Cup.
Product codes (comma separated list FDA assigned to the subject device)
LZO
Device Description
The Responsive Orthopedics Total Hip Arthroplasty (RO THA) System is a total hip system that allows for the restoration of alignment, stability and range of motion, and alleviates pain, by replacing the articulating surfaces of the hip joint. The system includes both femoral and acetabular components. The implants are available in a variety of sizes to accommodate varying patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint, proximal femur
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)
The following performance bench testing was performed for the Responsive Orthopedics Total Hip Arthroplasty System in support of the substantial equivalence determination.
The tests completed were:
- -Femoral Stem Fatigue Testing
- Femoral Neck Fatigue Testing -
- Axial Disassembly Testing -
- -Fretting and Corrosion Testing
- -Cup and Liner Disassembly Testing
- Screw Characteristics Testing -
- Ceramic Femoral Head Comparative Burst Testing -
- Ceramic Femoral Head Fatigue and Post-Fatigue Burst Testing -
- Ceramic Femoral Head Axial Disassembly Testing -
- Ceramic Femoral Head Torque Testing -
- -Pyrogenicity Testing
Wear and impingement performance of the conventional, non-crosslinked polyethylene liners in the subject system were addressed based on a comparison of the minimum thickness in the rim and load-bearing regions of the liners with the predicate devices.
All tests which are in relation to the porous structure characterization (physical, chemical or mechanical) are in Master File MAF - 628 (owned by APS Materials) and are not included in this 510(k).
The subject devices met the pre-determined acceptance criteria for all tests. Therefore, design verification testing determined that the subject devices are substantially equivalent to the predicate devices.
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.
K001991, K920430, K932755, K050262, K110245, K111546, K022520, K062775
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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2017
Responsive Orthopedics, LLC % Ms. Kathy Remsen Senior Program Manager, Regulatory Affairs Medtronic, Inc. 2600 Sofamor Danek Drive Memphis, Tennessee 38132
Re: K163585
Trade/Device Name: Responsive Orthopedics Total Hip Arthroplasty 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: LZO Dated: April 28, 2017 Received: May 1, 2017
Dear Ms. Kathy Remsen:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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/ResourcesforYou/Industry/default.htm. 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.
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,
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)
Device Name
Responsive Orthopedics Total Hip Arthroplasty System
Indications for Use (Describe)
The Responsive Orthopedics Total Hip Arthroplasty System is indicated for cementless use only in the following cases:
- · Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- · Rheumatoid arthritis;
- · Correction of functional deformity;
- · Revision procedures where other treatments or devices have failed; and
· Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The Responsive Orthopedics Total Hip Arthroplasty System Acetabular screws are indicated for supplemental fixation of Responsive Orthopedics Acetabular Cup.
| 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)
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RESPONSIVE ORTHOPEDICS TOTAL HIP ARTHROPLASTY SYSTEM 510(k) SUMMARY May 2017
-
l. Submitter Responsive Orthopedics, LLC 5865 East State Road 14 Columbia City, IN 46725
Phone Number 901-344-1584 -
Contact Kathy Remsen Senior Program Manager, Regulatory Affairs
-
Date Prepared May 24, 2017
-
II. Device
| Name of Device | Responsive Orthopedics Total Hip Arthroplasty System |
|---|---|
| ---------------- | ------------------------------------------------------ |
Common Name Semi-constrained total hip prosthesis
Classification Name Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented -- LZO
-
Class II Classification
Product Codes LZO 21 CFR 888.3353 -
Predicates Depuy Summit Tapered Hip System K001991, S.E. 08/25/2000
Smith&Nephew -- REFLECTION K920430, S.E. 07/21/1992 K932755, S.E. 05/06/1994
United Orthopedic Corporation - U2 Acetabular Components K050262, S.E. 08/15/2005
United Orthopedic Corporation - UTF Stem System K110245, S.E. 08/04/2011
United Orthopedic Corporation - U2 Femoral Head
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K111546, S.E. 07/01/2011 K103479, S.E. 03/10/2011 K022520, S.E. 02/25/2003
Ortho Development Corporation - Ovation™ Hip Stem K062775, S.E. 01/16/2007
The predicates have not been subject to a design related recall.
III. Product Description
The Responsive Orthopedics Total Hip Arthroplasty (RO THA) System is a total hip system that allows for the restoration of alignment, stability and range of motion, and alleviates pain, by replacing the articulating surfaces of the hip joint. The system includes both femoral and acetabular components. The implants are available in a variety of sizes to accommodate varying patient anatomy.
IV. Indications for Use:
The Responsive Orthopedics Total Hip Arthroplasty System is indicated for cementless use only in the following cases:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and ●
- Nonunions, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.
The Responsive Orthopedics Acetabular screws are intended for supplemental fixation of Responsive Orthopedics Acetabular Cup.
V. Comparison of Technological Characteristics
The subject Responsive orthopedics Total Hip Arthroplasty System has the same or similar indications, intended use, and materials as the following FDA-cleared predicates K001991 (S.E. 08/25/2000), K920430 (S.E. 07/21/1992), K932755 (S.E. 05/06/1994), K050262 (S.E. 08/15/2005), K110245 (S.E. 08/04/2011), K111546 (S.E. 07/01/2011), K111546 (S.E. 07/01/2011), K022520 (S.E. 02/25/2003), and K062775 (S.E. 01/16/2007). The predicate and subject devices have the same function.
VI. Materials
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The RO THA Femoral Stems and acetabular cups are manufactured from forged Ti-6AI-4V ELI conforming to ASTM F136 and ASTM F620.
The RO THA Acetabular Screws are manufactured from machined Ti-6AL-4V ELI conforming to ASTM F136.
The RO THA Femoral heads are manufactured from Co-Cr-Mo alloy conforming to ASTM F1537 and from BIOLOX® delta.
The RO THA Acetabular Liners are manufactured from conventional, noncrosslinked GUR1020 UHMWPE conforming to ASTM F648.
VII. Performance Data
The following performance bench testing was performed for the Responsive Orthopedics Total Hip Arthroplasty System in support of the substantial equivalence determination.
The tests completed were:
- -Femoral Stem Fatigue Testing
- Femoral Neck Fatigue Testing -
- Axial Disassembly Testing -
- -Fretting and Corrosion Testing
- -Cup and Liner Disassembly Testing
- Screw Characteristics Testing -
- Ceramic Femoral Head Comparative Burst Testing -
- Ceramic Femoral Head Fatigue and Post-Fatigue Burst Testing -
- Ceramic Femoral Head Axial Disassembly Testing -
- Ceramic Femoral Head Torque Testing -
- -Pyrogenicity Testing
Wear and impingement performance of the conventional, non-crosslinked polyethylene liners in the subject system were addressed based on a comparison of the minimum thickness in the rim and load-bearing regions of the liners with the predicate devices.
All tests which are in relation to the porous structure characterization (physical, chemical or mechanical) are in Master File MAF - 628 (owned by APS Materials) and are not included in this 510(k).
The subject devices met the pre-determined acceptance criteria for all tests. Therefore, design verification testing determined that the subject devices are substantially equivalent to the predicate devices.
VIII. Conclusions
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Based on the test results and additional supporting information provided in this pre-market notification, the subject devices demonstrated substantial equivalence to the legally marketed predicate devices.