(28 days)
No
The document describes a mechanical implant (total hip system) and its components. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes
Explanation: The device is indicated for use in total hip replacement surgery to treat conditions like osteoarthritis and avascular necrosis, which makes it a therapeutic device aimed at treating a disease or condition.
No
The device description indicates that the iNSitu Total Hip System is an implant used for total hip replacement, and nowhere in the provided text is there any mention of diagnostic capabilities.
No
The device description clearly states it is a "Blade Femoral Stem" made from titanium alloy and is part of a "Total Hip System" which includes physical implants and instruments. This is a hardware medical device.
Based on the provided text, 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 iNSitu Total Hip System is a system of implants (femoral stems, acetabular cups, etc.) intended for surgical implantation in the body for total hip replacement.
- Intended Use: The intended use describes the surgical procedure and the conditions for which the implant is used, not diagnostic testing of samples.
The device is a surgical implant, not a diagnostic test performed on samples outside the body.
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
LPH, OQG, LZO, OQI
Device Description
The subject device of this 510(k) notification is the Blade Femoral Stem, which is a line extension to the iNSitu Total Hip System. The Blade Femoral Stem is a collarless dual-tapered for biologic fixation. The neck is polished and narrowed in the anterior-posterior dimension to reduce the potential for impingement with the liner and to increase the range of motion (ROM), while maintaining flexural rigidity. The proximal portion of the stem possesses a porous structured commercially pure (CP) titanium coating for biologic fixation with bone. The hip stem has a smooth satin finish. There is a range of sizes that proportionally increase in diameter, stem length, and neck offset to accommodate a range of human hip anatomy. The range of stem sizes is offered in both standard and lateralized neck configurations. The Blade Femoral Stem is made from titanium alloy conforming to ASTM F136.
The iNSitu Total Hip System includes a family of femoral stems (including the predicate iNSitu Femoral Stems and the subject Blade Femoral Stems), femoral head components, UHMWPE acetabular cups, acetabular hole covers, optional acetabular screws, instruments, and sterilization cases. With the extension Blade Femoral Stem, all other components of the subject device are identical to the predicate devices cleared in K161184 and 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 intended 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
Prescription Use
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
Performance testing was conducted on the subject iNSitu Total Hip System Blade Femoral Stems to evice and to demonstrate substantial equivalence to the legally marketed predicate. The results confirm that the subject Blade Femoral Stem components are substantially equivalent to the predicate femoral stems.
- Distal fatigue testing of the worst-case Blade Femoral Stem was conducted.
- Proximal fatigue testing of the neck region of the worst-case Blade Femoral Stem was conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 30, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Theken Companies, LLC % Robert Poggie President BioVera, Inc. 65 Promenade Saint Louis Notre Dame de L'Ile Perrot, J7V7P2 CA
Re: K192071
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 31, 2019 Received: August 2, 2019
Dear Robert 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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,
For 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
2
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K192071
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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3
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 29, 2019 |
| Establishment Registration Number: | 3002498892 |
510(k) Contact
| Contact: | BioVera, Inc. |
|---|---|
| Address: | Notre-Dame-de-L'Ile-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 line extension, specifically a dual-tapered (Blade) Femoral Stem, to the iNSitu Total Hip System (K161184/K172501).
| 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 |
4
Device Description
The subject device of this 510(k) notification is the Blade Femoral Stem, which is a line extension to the iNSitu Total Hip System. The Blade Femoral Stem is a collarless dual-tapered for biologic fixation. The neck is polished and narrowed in the anterior-posterior dimension to reduce the potential for impingement with the liner and to increase the range of motion (ROM), while maintaining flexural rigidity. The proximal portion of the stem possesses a porous structured commercially pure (CP) titanium coating for biologic fixation with bone. The hip stem has a smooth satin finish. There is a range of sizes that proportionally increase in diameter, stem length, and neck offset to accommodate a range of human hip anatomy. The range of stem sizes is offered in both standard and lateralized neck configurations. The Blade Femoral Stem is made from titanium alloy conforming to ASTM F136.
The iNSitu Total Hip System includes a family of femoral stems (including the predicate iNSitu Femoral Stems and the subject Blade Femoral Stems), femoral head components, UHMWPE acetabular cups, acetabular hole covers, optional acetabular screws, instruments, and sterilization cases. With the extension Blade Femoral Stem, all other components of the subject device are identical to the predicate devices cleared in K161184 and 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 intended 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, 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 line extension of new sizes (iNSitu Total Hip System Blade Femoral Stem) are cleaned, packaged, and sterilized using the same processes as the family of femoral stems in the iNSitu Total Hip System (K161184/K172501). The subject Blade Femoral Stem includes additional stem length options, a modified proximal cross-section, and a new coating application method. The new sizes represented in the subject Blade Femoral Stems are substantially equival iNStu Total Hip System (K161184/K172501) based on comparisons of intended use, design features, and technological characteristics.
Performance Testing
Performance testing was conducted on the subject iNSitu Total Hip System Blade Femoral Stems to evice and to demonstrate substantial equivalence to the legally marketed predicate. The results confirm that the subject Blade Femoral Stem components are substantially equivalent to the predicate femoral stems.
- Distal fatigue testing of the worst-case Blade Femoral Stem was conducted.
- . Proximal fatigue testing of the neck region of the worst-case Blade Femoral Stem was conducted.
Conclusions
The subject iNSitu Total Hip System Blade Femoral Stems are manufactured from similar materials and have the same indications for use as the predicate hip systems (K161184/K172501). A comparison of technological characteristics and performance testing demonstrate the iNSitu Total Hip System Blade Femoral Stems is substantially equivalent to the predicate system (K161184/K172501).