(32 days)
Not Found
No
The summary describes a mechanical implant system for total hip replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for total hip replacement due to various medical conditions, aiming to treat or alleviate a disease or injury.
No
The device description clearly states it is a total hip replacement system, which is a prosthetic implant for surgical replacement of a joint, not a tool for diagnosing medical conditions.
No
The device description explicitly lists hardware components such as femoral stems, femoral head components, acetabular liners, acetabular cups, hole covers, screws, instruments, and sterilization cases.
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 total hip replacement. This is a medical device used in vivo (within the body) to replace a damaged joint.
- Device Description: The description details physical components like femoral stems, heads, liners, and cups, which are all parts of a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from a patient, while this device is a physical implant used during surgery.
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, theumator 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 NextStep Arthropedix Total Hip Replacement System includes a family of femoral stems, femoral head components, acetabular UHMWPE liners, acetabular cups (including solid, 3-holed, and the subject multiholed), acetabular hole covers, optional acetabular screws, instruments, and sterilization cases (K161184/K172501). The implants are packaged in single use, sterile packages with a 5-year shelf life and the re-usable instruments are contained in sterilization cases for steam sterilization.
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)
- 2-point fatigue testing was performed on the multi-holed acetabular cup to show substantial equivalence to the predicate device.
- Risk based EO sterilization was performed to document that the newly introduced iNSitu Multi-Holed Acetabular Cup did not present a new worst-case scenario, and therefore included into the documentation for the existing sterilization process for the predicate device (K161184/K172501).
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
August 20, 2019
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Theken Companies, LLC % Robert A. Poggie, Ph.D. President BioVera, Inc. 65 Promenade Saint-Louis Notre-Dame-De-I'lle-Perrot, Quebec, J7V 7P2, Canada
Re: K191936
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: July 17, 2019 Received: July 19, 2019
Dear Dr. Poggie:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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, theumator 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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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: | August 9, 2019 | |
| Establishment Registration Number: | 3002498892 |
510(k) Contact
| Contact: | BioVera, Inc. |
|---|---|
| Address: | Notre-Dame-de-L'lle-Perrot (QC) J7V 7P2, CA |
| Phone Number: | 514-901-0796 |
| Fax Number: | 514-901-0796 |
| Contact Person: | Robert A Poggie, PhD |
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) |
Legally Marketed Predicate
This Special 510(k) submission is to add a multi-holed acetabular cup to the iNSitu Total Hip System (K161184/K172501). The Primary Predicate Device for this system is K161184.
| Company | Device Name | 510(k) Number(s) | Clearance Date |
|---|---|---|---|
| Theken | iNSitu Total Hip System | K161184 | 10/14/2016 |
| Theken | iNSitu Total Hip System | K172501 | 09/21/2017 |
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Device Description
The NextStep Arthropedix Total Hip Replacement System includes a family of femoral stems, femoral head components, acetabular UHMWPE liners, acetabular cups (including solid, 3-holed, and the subject multiholed), acetabular hole covers, optional acetabular screws, instruments, and sterilization cases (K161184/K172501). The implants are packaged in single use, sterile packages with a 5-year shelf life and the re-usable instruments are contained in sterilization cases for steam sterilization.
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, traumatic 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, internal fixation, 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 multi-holed acetabular cups are manufactured from the same materials and processes as the family of acetabular cups in the original iNSitu Total Hip System (K161184/K172501). All iNSitu Total Hip System components, including the subject multi-holed acetabular cup, are cleaned, packaged and sterilized using the same processes as previously described in K161184/K172501. The subject multi-holed acetabular cup is substantially equivalent to the original iNSitu Total Hip System (K161184/K172501) acetabular cup but includes multi-holed options for fixation into the acetabulum. The subject multi-holed acetabular cup is equivalent to the original acetabular cup based on comparisons of intended use, design features, and technological characteristics.
Performance Testing
Performance testing was conducted on the iNSitu Total Hip System multi-holed acetabular cup to evaluate the device and to demonstrate substantial equivalence. The results confirm that the multi-holed acetabular cup components are substantially equivalent to the predicate acetabular cup.
- 2-point fatigue testing was performed on the multi-holed acetabular cup to show substantial equivalence to the predicate device.
- Risk based EO sterilization was performed to document that the newly introduced iNSitu Multi-Holed Acetabular Cup did not present a new worst-case scenario, and therefore included into the documentation for the existing sterilization process for the predicate device (K161184/K172501).
Conclusions
The iNSitu Total Hip System multi-holed acetabular cup has the indications for use as the iNSitu Total Hip System acetabular cup predicate device. A comparison of technological characteristics and performance testing demonstrates that the NextStep Arthropedix iNSitu Total Hip System multi-holed acetabular cup is substantially equivalent to the predicate system (K161184/K172501).