(34 days)
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No
The document describes a mechanical implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a total hip replacement system, which replaces parts of the hip joint to alleviate pain and restore function in individuals with severe joint issues, thus providing therapeutic benefit.
No.
Explanation: The iNSitu Total Hip System is described as an artificial total hip replacement system, which is a therapeutic device, not a diagnostic one. Its intended use is for replacing a joint, not for diagnosing a condition.
No
The device description explicitly lists multiple hardware components (femoral stems, femoral heads, acetabular cups, etc.) made from various materials, indicating it is a physical implant system, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly describes a surgical implant used for total hip replacement. It is a physical device implanted into the body to replace a damaged hip joint.
- Lack of Diagnostic Activity: There is no mention of this device analyzing biological samples or providing diagnostic information. Its function is purely mechanical and structural.
Therefore, based on the provided information, the iNSitu Total Hip System is a surgical implant, 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, traumator 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, OQG, LZO, OQI
Device Description
The iNSitu Total Hip Replacement System is an artificial total hip replacement system includes femoral stems manufactured from forged Ti 6Al-4V ELI material, femoral heads manufactured from CoCr alloy and BIOLOX® delta ceramic, acetabular cups (additively manufactured from Ti), acetabular liners manufactured from Vitamin E polyethylene, acetabular bone screws, screw hole covers for the screw holes in the acetabular cups, and apical hole covers for the apical hole in the acetabular cups manufactured from Ti 6Al-4V ELI material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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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)
Performance testing was conducted on the iNSitu Total Hip System femoral stems to evaluate the device and to demonstrate substantial equivalence. The results confirm that the femoral stem components are substantially equivalent to the predicate femoral stems.
- Fatigue testing of the worst-case distal femoral hip stem was conducted.
- . Fatigue testing of the neck region of the worst-case femoral hip stem was conducted.
There were no clinical tests performed for this submission.
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).
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.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and 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, with three figures in profile facing right, representing the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Theken Companies, LLC Dale Davison VP - Engineering 1800 Triplett Blvd Akron, Ohio 44306
September 21, 2017
Re: K172501 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, OQG, LZO, OQI Dated: August 28, 2017 Received: August 31, 2017
Dear Dale Davison:
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
1
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 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 (DICE) 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 (DICE) 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
2
Indications for Use
510(k) Number (if known)
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, traumator 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) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image is a logo for Next Step Arthropedix. The logo features the letters "NS" in a bold, stylized font, with a graphic of a cat incorporated into the design. Below the letters, the words "NEXT STEP" are written in a modern font, with the word "STEP" in a light purple color. Underneath "NEXT STEP", the word "ARTHROPEDIX" is written in smaller letters.
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: | September 19, 2017 |
| Establishment Registration Number: | 3002498892 |
510(k) Contact
| Contact: | Theken Companies, LLC |
|---|---|
| Address: | 1800 Triplett Blvd., Akron, OH 44306 |
| Phone Number: | 330.733.7600 |
| Fax Number: | 330.733.7602 |
| Contact Person: | Dale Davison |
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 |
| Product Codes: | LPH |
| OQG | |
| LZO | |
| OQI | |
| Advisory Panel: | 87 (Orthopedic) |
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Legally Marketed Predicate
This Special 510(k) submission is to add additional stem sizes to the iNSitu Total Hip System (K161184 SE 10/14/16).
| Company | Device Name | 510(k) Number(s) | Clearance Date |
|---|---|---|---|
| Theken | iNSitu Total Hip System | K161184 | 10/14/2016 |
Device Description
The iNSitu Total Hip Replacement System is an artificial total hip replacement system includes femoral stems manufactured from forged Ti 6Al-4V ELI material, femoral heads manufactured from CoCr alloy and BIOLOX® delta ceramic, acetabular cups (additively manufactured from Ti), acetabular liners manufactured from Vitamin E polyethylene, acetabular bone screws, screw hole covers for the screw holes in the acetabular cups, and apical hole covers for the apical hole in the acetabular cups manufactured from Ti 6Al-4V ELI material.
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, rheumatoid arthritis, 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 new sizes of femoral stems are manufactured from the same materials and processes as the family of femoral stems in the original iNSitu Total Hip System (K161184 SE 10/14/16). All iNSitu Total Hip System components are cleaned, packaged and sterilized using the same processes. The new sizes of femoral stems are substantially equivalent to the original iNSitu Total Hip System (K161184 SE 10/14/16) based on comparisons of intended use, design features, materials, and technological characteristics.
Performance Testing
Performance testing was conducted on the iNSitu Total Hip System femoral stems to evaluate the device and to demonstrate substantial equivalence. The results confirm that the femoral stem components are substantially equivalent to the predicate femoral stems.
- Fatigue testing of the worst-case distal femoral hip stem was conducted.
- . Fatigue testing of the neck region of the worst-case femoral hip stem was conducted.
There were no clinical tests performed for this submission.
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 NextStep Arthropedix Total Hip System is substantially equivalent to the predicate system (K161184).