(170 days)
Not Found
No
The summary describes a mechanical hip replacement system and its components, with performance studies focused on mechanical properties and wear. There is no mention of AI or ML.
Yes
The device is a total hip replacement system, which replaces diseased or damaged joints to restore function and alleviate pain, thus providing therapy.
No
The device is described as an "artificial hip replacement system" and its intended use is for total hip replacement surgery, indicating it is an implantable therapeutic device, not a diagnostic one.
No
The device description explicitly lists multiple hardware components including femoral stems, femoral heads, acetabular cups, liners, screws, and covers. The performance studies also detail extensive mechanical and physical testing of these hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the iNSitu Total Hip System is for surgical implantation in skeletally mature individuals undergoing total hip replacement. This is a surgical procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description lists components of an artificial hip joint (stems, heads, cups, liners, screws, covers). These are implantable medical devices, not reagents, instruments, or systems used to examine specimens from the human body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening
The iNSitu Total Hip System is an implantable medical device used for surgical treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The iNSitu Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:
· A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia:
· Acute traumatic fracture of the femoral head or neck;
· Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement
The iNSitu Total Hip System femoral stem is intended for cementless fixation. The iNSitu Total Hip System acetabular cup is intended for cementless fixation. The porous structured surfaces provide biological fixation in a cementless application.
Product codes (comma separated list FDA assigned to the subject device)
LPH, OOG, LZO, OOI
Device Description
The iNSitu Total Hip Replacement System is an artificial hip replacement system. The system includes femoral stems, femoral heads, acetabular cups (additively manufactured), acetabular liners (Vitamin E polyethylene), acetabular bone screws, screw hole covers for the scetabular cups, and apical hole covers for the apical hole in the acetabular cups.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
skeletally mature individuals
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)
Extensive preclinical performance testing was conducted on the iNSitu Total Hip System to evaluate the device and to demonstrate substantial equivalence. The results confirm that all components of the iNSitu Total Hip System exhibit the appropriate mechanical characteristics for total hip joint replacement, and are substantially equivalent to the predicate devices.
- Modular acetabular component disassembly testing was conducted. Liner push-out, offset pull-out, and torsional testing was conducted on worst-case sizes.
- Testing of the torsional and fixation strength and removal torque of the iNSitu acetabular bone screws was conducted.
- . Physical, mechanical, thermal, cross-link, and oxidation properties of the iNSitu highly cross-linked vitamin E stabilized UHMWPE were characterized.
- Hip wear simulator testing was conducted on the worst-case components of the iNSitu Total Hip System.
- . Impingement testing was conducted on the worst-case components of the iNSitu Total Hip System.
- . The range of motion of the iNSitu Total Hip System was evaluated in flexion/extension, abduction/adduction, and internal/external rotation.
- Characterization of the porous structured titanium was conducted in accordance with FDA Guidance "Guidance Document for Testing Orthopedic Implants with Surfaces Apposing Bone or Bone Cement."
- . The physical and mechanical properties of the iNSitu AM titanium alloy solid implant substrate (nonporous base material) were fully characterized.
- . An unsupported fatigue test was conducted on the iNSitu acetabular cup.
- . Mechanical and fatigue testing of the ceramic femoral heads was conducted.
- . Disassembly testing of the femoral head/femoral taper was conducted with both CoCr and ceramic femoral heads.
- . Fatigue testing of the worst-case femoral hip stem was conducted.
- Fatigue testing of the neck region of the worst-case femoral hip stem was conducted.
- The Bacterial Endotoxins Test (BET), chromogenic kinetic method, was performed.
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
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a family of three people, with the heads overlapping to create a sense of unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 2016
Theken Companies, LLC % Mrs. Hollace Rhodes Director. Orthopedic Regulatory Affairs Musculosketal Clinical Regulatory Advisors, LLC (MCRA) 1331 H Street N.W., 12th Floor Washington, District of Columbia 20005
Re: K161184 Trade/Device Name: iNSitu Total Hip 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, OOG, LZO, OOI Dated: September 13, 2016 Received: September 14, 2016
Dear Mrs. Rhodes:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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" (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,
Image /page/1/Picture/8 description: The image shows the name "Mark N. Melkerson -S" in a simple, sans-serif font. The text is horizontally aligned and appears to be part of a document or presentation. The letters are clear and legible, with consistent spacing.
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) K161184
Device Name
iNSitu Total Hip System
Indications for Use (Describe)
The iNSitu Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:
· A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia:
· Acute traumatic fracture of the femoral head or neck;
· Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement
The iNSitu Total Hip System femoral stem is intended for cementless fixation. The iNSitu Total Hip System acetabular cup is intended for cementless fixation. The porous structured surfaces provide biological fixation in a cementless application.
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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510(k) Summary
The following 510(k) Summary is provided in accordance with 21 CFR 807.92.
510(k) Owner and Registration
| Owner's Name: | Theken Companies, LLC
Subsidiary: NextStep Arthropedix | |
|------------------------------------|-----------------------------------------------------------|--|
| Address: | 1800 Triplett Blvd., Akron, OH 44306 | |
| Phone Number: | (330) 733-7600 | |
| Fax Number: | (330) 733-7602 | |
| Date Summary Prepared: | October 14, 2016 | |
| Establishment Registration Number: | Not yet registered | |
510(k) Contact
| Contact: | Musculoskeletal Clinical Regulatory Advisers, LLC |
|---|---|
| Address: | 1331 H Street NW, 12th Floor, Washington DC, 20005 |
| Phone Number: | (202) 552-5800 |
| Fax Number: | (202) 552-5798 |
| Contact Person: | Hollace Saas Rhodes |
Device Name and Classification
| Device Trade Name: | iNSitu Total Hip System |
|---|---|
| Device Common Name: | Total Hip Replacement |
| Regulation Number and Description: | 21 CFR 888.3358 |
| 21 CFR 888.3353 | |
| Device Class: | Class II |
| Classification Product Code: | LPH |
| OQG | |
| LZO | |
| OQI | |
| Advisory Panel: | 87 (Orthopedic) |
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Legally Marketed Predicate
NextStep Arthropedix is utilizing these predicates to demonstrate substantial equivalence to a legally marketed predicate. The Pipeline RESTORIS® Hip System is considered the primary predications for use) and the Consensus TaperSet™ Stem and CS2™ Acetabular System are included for performance comparisons.
| Company | Device Name | 510(k) Number(s) | Clearance Date |
|---|---|---|---|
| Pipeline | Restoris Stem and | ||
| Restoris PST Cup | K131237 | 6/13/2013 | |
| Consensus | TaperSet Stem and CS2 | ||
| Cup | K121935, | ||
| K141043 | 9/10/2012, | ||
| 5/19/2014 |
Device Description
The iNSitu Total Hip Replacement System is an artificial hip replacement system. The system includes femoral stems, femoral heads, acetabular cups (additively manufactured), acetabular liners (Vitamin E polyethylene), acetabular bone screws, screw hole covers for the scetabular cups, and apical hole covers for the apical hole in the acetabular cups.
Intended Use
The iNSitu Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:
- . A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia;
- Acute traumatic fracture of the femoral head or neck;
- Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement
The iNSitu Total Hip System femoral stem is intended for cementless fixation. The iNSitu Total Hip System acetabular cup is intended for cementless fixation. The porous structured surfaces provide biological fixation in a cementless application.
Summary of Technological Characteristics
The iNSitu Total Hip System is manufactured from titanium alloy. The iNSitu Total Hip System components are packaged and sterilized using similar processes. The subject system is substantially equivalent to the predicates based on comparisons of intended use, design features, and technological characteristics.
Performance Testing
Extensive preclinical performance testing was conducted on the iNSitu Total Hip System to evaluate the device and to demonstrate substantial equivalence. The results confirm that all components of the iNSitu Total Hip System exhibit the appropriate mechanical characteristics for total hip joint replacement, and are substantially equivalent to the predicate devices.
- Modular acetabular component disassembly testing was conducted. Liner push-out, offset pull-out, and torsional testing was conducted on worst-case sizes.
- Testing of the torsional and fixation strength and removal torque of the iNSitu acetabular bone screws was conducted.
- . Physical, mechanical, thermal, cross-link, and oxidation properties of the iNSitu highly cross-linked vitamin E stabilized UHMWPE were characterized.
- Hip wear simulator testing was conducted on the worst-case components of the iNSitu Total Hip System.
5
- . Impingement testing was conducted on the worst-case components of the iNSitu Total Hip System.
- . The range of motion of the iNSitu Total Hip System was evaluated in flexion/extension, abduction/adduction, and internal/external rotation.
- Characterization of the porous structured titanium was conducted in accordance with FDA Guidance "Guidance Document for Testing Orthopedic Implants with Surfaces Apposing Bone or Bone Cement."
- . The physical and mechanical properties of the iNSitu AM titanium alloy solid implant substrate (nonporous base material) were fully characterized.
- . An unsupported fatigue test was conducted on the iNSitu acetabular cup.
- . Mechanical and fatigue testing of the ceramic femoral heads was conducted.
- . Disassembly testing of the femoral head/femoral taper was conducted with both CoCr and ceramic femoral heads.
- . Fatigue testing of the worst-case femoral hip stem was conducted.
- Fatigue testing of the neck region of the worst-case femoral hip stem was conducted.
- The Bacterial Endotoxins Test (BET), chromogenic kinetic method, was performed.
Conclusions
The iNSitu Total Hip System has the same indications for use as predicate hip systems. A comparison of technological characteristics and performance testing demonstrates that the iNSitu Total Hip System is substantially equivalent to the predicate systems.