(235 days)
Not Found
No
The summary describes a mechanical implant (total hip system) and its components, focusing on material properties and mechanical testing. There is no mention of AI, ML, image processing, or data-driven algorithms.
Yes.
The device is a component of a total hip replacement system, which is used to alleviate pain and disability in patients with severe joint conditions, indicating its therapeutic purpose.
No
The device is a hip replacement system, not a device used to identify or analyze a condition. It is a prosthetic device for treatment.
No
The device description and performance studies clearly indicate this is a physical medical device (ceramic femoral head) used in total hip replacement surgery, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for total hip replacement surgery in skeletally mature individuals due to various conditions affecting the hip joint. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a ceramic femoral head, a component of a total hip replacement system. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
- Performance Studies: The performance studies focus on the mechanical strength and performance of the implant itself, not on its ability to diagnose a condition.
In summary, the iNSitu Total Hip System is a surgical implant used for treatment, not a device used to perform diagnostic tests outside of 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, 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 stems are 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 subject device Mg-PSZ Ceramic Femoral Head is manufactured from Zirconia Mg-PSZ ceramic material, which is the same material that comprises the predicate BioPro Ziralloy modular ceramic head. The subject device Mg-PSZ Ceramic Femoral Heads, including all sizes and offsets, have the same or similar design features and indications for use as the primary predicate device (Biolox Delta ceramic femoral head). The NextStep Arthropedix Mg-PSZ Ceramic Femoral Heads are packaged and sterilized using identical processes as the primary predicate device Biolox Delta femoral heads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip Joint
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)
Preclinical performance testing was conducted on NextStep Arthropedix Mg-PSZ Ceramic Femoral Heads to evaluate the device strength and performance characteristics and demonstrate substantial equivalence. The results demonstrated that the NextStep Arthropedix Mg-PSZ Ceramic Femoral Head exhibits appropriate mechanical and performance characteristics for total hip joint replacement and is substantially equivalent to the predicate devices.
- Testing of the ceramic femoral heads was conducted per ISO7206-10 and ASTMF2345 for:
- Static Burst-Strength Testing
- Fatigue Testing
- Static Burst-Strength, Post-Fatigue Testing
- Disasembly testing of the femoral head/femoral taper was conducted per ISO7206-10 and ASTM F2009, and torque testing according to ISO 7206-13 for:
- Static Pull-Off (Axial) Strength
- Static Torque-Off/Strength
- The iNSitu Mg-PSZ Ceramic Femoral Head was tested per the material requirements specified in ASTM F2393.
Engineering analysis and mechanical testing of the subject and primary predicate devices demonstrated that the difference in ceramic material and subtle design differences in tapers did not result in new and/or adverse changes in performance characteristics.
Bacterial endotoxin testing met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
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.
K161184, K912641, K925682, K172501, K192071, K191936
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/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 30, 2022
Theken Companies % Robert Poggie President BioVera, Inc. 65 Promenade Saint Louis Notre-Dame-de-L'Ile-Perrot, Quebec J7V-7P2 Canada
Re: K220336
Trade/Device Name: Mg-PSZ Ceramic Femoral Heads 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 15, 2022 Received: August 16, 2022
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.
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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 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
Limin Sun, Ph.D. 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K220336
Device Name Mg-PSZ Ceramic Femoral Head
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 stems are 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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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 31, 2022 |
| Establishment Registration Number: | 3002498892 |
510(k) Contact
| Contact: | BioVera, Inc. |
|---|---|
| Address: | Notre-Dame-de-L'Ile-Perrot, (QC), J7W-3J6, Canada |
| Phone and Fax Number: | 514-901-0796 |
| Contact Person: | Robert A Poggie, PhD |
Subject Device Name and Classification
| Device Trade Name: | Mg-PSZ Ceramic Femoral Head |
|---|---|
| Device Common Name: | Femoral Head |
| Primary predicate device: | NextStep Arthropedix Biolox Delta ceramic femoral |
| head, K161184 | |
| Additional predicate devices: | BioPro Ziralloy modular ceramic femoral head, K912641, |
| K925682 | |
| NextStep Arthropedix Biolox Delta ceramic femoral | |
| head, K172501, K192071, K191936 | |
| Regulation Number and Description: | 21 CFR 888.3358 |
| 21 CFR 888.3353 | |
| Device Class: | Class II |
| Product Codes: | LPH |
| Subsequent Product Codes: | OQG, LZO, OQI |
| Advisory Panel: | 87 (Orthopedic) |
Legally Marketed Predicate Devices
The NextStep Arthropedix Biolox Delta ceramic femoral head is the primary predicate device, which is part of the iNSitu Total Hip system that includes femoral hip stems, acetabular liners, bone screws, and OCr and ceramic femoral heads (K161184, K192071, K191936). The subject device Mg-PSZ ceramic femoral head is made from the same material as the additional predicate device, the BioPro Ziralloy modular ceramic femoral head (K912641, K925682).
Device Description
The subject device Mg-PSZ Ceramic Femoral Head is manufactured from Zirconia Mg-PSZ ceramic material, which is the same material that comprises the predicate BioPro Ziralloy modular ceramic head. The subject device Mg-PSZ Ceramic Femoral Heads, including all sizes and offsets, have the same or similar design features and indications for use as the
4
primary predicate device (Biolox Delta ceramic femoral head). The NextStep Arthropedix Mg-PSZ Ceramic Femoral Heads are packaged and sterilized using identical processes as the primary predicate device Biolox Delta femoral heads.
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, 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 stems are 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 subject device Mg-PSZ Ceramic Femoral Heads, including all sizes and offsets, have the same or similar design features and indications for use as the primary predicate device (Biolox Delta ceramic femoral head). The main difference between the primary predicate and subject device ceramic heads is the subject device is manufactured from Zirconia Mg-PSZ ceramic, while the primary predicate device is manufactured from Biolox Delta ceramic. The Zirconia Mg-PSZ material that comprises the subject device Mg-PSZ Ceramic Femoral Head is identical that comprises the predicate BioPro Ziralloy modular ceramic head. The NextStep Arthropedix Mg-PSZ Ceramic Femoral Heads are packaged and sterliized using the same processes as the primary predicate device Biolox Delta femoral heads. The subject device is substantially equivalent to the predicate device based on comparisons of intended use, materials, and technological characteristics.
Performance Testing
Preclinical performance testing was conducted on NextStep Arthropedix Mg-PSZ Ceramic Femoral Heads to evaluate the device strength and performance characteristics and demonstrate substantial equivalence. The results demonstrated that the NextStep Arthropedix Mg-PSZ Ceramic Femoral Head exhibits appropriate mechanical and performance characteristics for total hip joint replacement and is substantially equivalent to the predicate devices.
- Testing of the ceramic femoral heads was conducted per ISO7206-10 and ASTMF2345 for:
- O Static Burst-Strength Testing
- o Fatigue Testing
- Static Burst-Strength, Post-Fatigue Testing O
- Disasembly testing of the femoral head/femoral taper was conducted per ISO7206-10 and ASTM F2009, and torque testing according to ISO 7206-13 for:
- Static Pull-Off (Axial) Strength o
- Static Torque-Off/Strength o
- The iNSitu Mg-PSZ Ceramic Femoral Head was tested per the material requirements specified in ASTM F2393.
Engineering analysis and mechanical testing of the subject and primary predicate devices demonstrated that the difference in ceramic material and subtle design differences in tapers did not result in new and/or adverse changes in performance characteristics.
Bacterial endotoxin testing met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
Conclusions
A comparison of technological characteristics and performance testing demonstrate that the NextStep Arthropedix Mg-PSZ Ceramic Femoral Head is substantially equivalent to the cited predicate devices.