(160 days)
No
The description focuses on patient-specific design based on CAD/CAM files generated from imaging and surgeon input, without mentioning AI or ML algorithms for image analysis, design generation, or surgical planning.
Yes
The device is a knee prosthesis, which is implanted to treat advanced knee osteoarthritis and correct varus deformity, thus it serves a therapeutic purpose.
No
This device is a patient-specific prosthesis (implant) designed for unicompartmental knee arthroplasty, which is a treatment for advanced knee osteoarthritis. It is not used for diagnosing medical conditions.
No
The device description clearly states that the Bodycad Unicompartmental Knee System (BUKS) is a patient-specific prosthesis consisting of femoral and tibial implants, which are physical hardware components. While software is used to generate the CAD/CAM files for manufacturing, the device itself is a physical implant system.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Bodycad Unicompartmental Knee System is a surgical implant designed to replace a damaged part of the knee joint. It is a physical device implanted into the patient's body.
- Intended Use: The intended use clearly states it is for "unicompartmental knee arthroplasty (UKA)," which is a surgical procedure.
- Device Description: The description details the materials and components of the implant itself.
- Performance Studies: The performance studies focus on the mechanical properties and surgical use of the implant, not on analyzing biological samples.
The device uses imaging (MRI or CT) to create a patient-specific implant, but this imaging is used for design and manufacturing purposes, not for diagnostic testing of a biological sample.
N/A
Intended Use / Indications for Use
The patient-specific Bodycad Unicompartmental Knee System (Bodycad UKS) is indicated for unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:
· joint impairment due to osteoarthritis or traumatic arthritis of the knee.
· varus deformity of the knee, and
· as an alternative to tibial osteotomy in patients with unicompartmental OA.
The patient-specific Bodycad UKS components fit within an envelope of dimensions that are specific to each patient. The Bodycad UKS femoral component and tibial baseplate are intended fixation. A Bodycad screw must be used for fixation of the femoral component.
Product codes
HSX
Device Description
The Bodycad Unicompartmental Knee System (BUKS) is a patient-specific prosthesis that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial components and single-use cutting quides are manufactured from CAD and CAM files generated from Bodycad software, which are based on MRI or CT images of the patient's knee and input from the surgeon. The BUKS is for cemented use only and is sterilized by gamma radiation.
The subject of this 510(k) notification is a line extension and design update that includes a new tibial baseplate that is compatible with the BUKS system (K163700, K181302) and instruments that are compatible with the new tibial baseplate.
Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (CoCrMo; ASTM F1537-11) for the femoral component and screw, wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (Ti6Al4V ELI; ASTM F136-13) for the tibial baseplate, locking pin, and screw, Ultra-High-Molecular-Weight Polyethylene (UHMWPE; F648-14) for the tibial insert.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI or CT images
Anatomical Site
Knee, medial tibiofemoral compartment
Indicated Patient Age Range
Not Found
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)
The following tests were performed for establishing substantial equivalence of subject, predicate, and reference devices:
- Tibial baseplate fatigue strength per 3-point bend method as described in ASTM F3140-17, Standard Test Method for Cyclic Fatique Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements, and ASTM F1800-12, Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements.
- Resistance to dislodgement of the polyethylene insert in both the as-manufactured and post cyclic fatigue conditions.
- Pull-out force for the locking pin at time-zero, as manufactured, and post cyclic fatigue.
- Surgeon-user validation, simulated surgeries with the new tibial baseplate, locking pin, insert, and associated instruments.
The results of performance testing demonstrated substantial equivalence of the subject, predicate, and reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two main elements: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" stacked in two lines.
October 8, 2019
% Robert Poggie President BioVera Inc. 65 Promenade Saint Louis Notre-Dame-de-l'Ile-Perrot, QC, J7V 7P2 Canada
Re: K191150
Trade/Device Name: Bodycad Unicompartmental Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX Dated: September 4, 2019 Received: September 9, 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 medical devices and radiation-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,
Digitally signed by Peter G. Peter G. Allen -S Date: 2019.10.08 Allen -S 11:44:53 -04'00'
For Ting Song Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Bodycad Unicompartmental Knee System
Indications for Use (Describe)
The patient-specific Bodycad Unicompartmental Knee System (Bodycad UKS) is indicated for unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:
· joint impairment due to osteoarthritis or traumatic arthritis of the knee.
· varus deformity of the knee, and
· as an alternative to tibial osteotomy in patients with unicompartmental OA.
The patient-specific Bodycad UKS components fit within an envelope of dimensions that are specific to each patient. The Bodycad UKS femoral component and tibial baseplate are intended fixation. A Bodycad screw must be used for fixation of the femoral component.
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
Bodycad Unicompartmental Knee System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness of the Bodycad Unicompartmental Knee System.
A. SUBMITTERS INFORMATION
| Submitter Name: | BioVera, Inc. |
|---|---|
| Submitter Address: | 65 Promenade Saint-Louis, Notre-Dame-De-L'Ile-Perrot, Quebec, |
| J7V 7P2, CANADA | |
| Contact Person: | Robert A Poggie, PhD |
| Phone Number: | (514) 901-0796 |
| Fax Number: | (514) 901-0796 |
| Date of Submission: | April 29, 2019 |
B. DEVICE IDENTIFICATION & MANUFACTURER
| Manufacturer Name: | Bodycad Laboratories Inc. |
|---|---|
| Manufacturer Address: | 2035 rue du Haut-Bord, Quebec, Quebec, G1N 4R7, Canada |
| Registration Number: | 3012086398 |
| Contact Name: | Guy Sevigny |
| Title: | Director, Regulatory Affairs |
| Device Trade Name: | Bodycad Unicompartmental Knee System |
| Device Common Name: | Unicondylar knee device |
| Classification Name: | knee joint femorotibial metal/polymer non-constrained, cemented |
| Classification Code: | HSX - Class II |
| Classification Panel: | Orthopedic |
| Regulation Number: | 21 CFR section 888.3520 |
C1. PREDICATE DEVICE
| K163700 | Bodycad Unicompartmental Knee System (BUKS) |
|---|---|
| K181302 | Bodycad Unicompartmental Knee System (BUKS) |
| C2. REFERENCE DEVICE | |
|---|---|
| K033363 | Zimmer Unicompartmental Knee System (ZUK) |
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D. DEVICE DESCRIPTION
The Bodycad Unicompartmental Knee System (BUKS) is a patient-specific prosthesis that consists of femoral and tibial implants for replacement of the medial tibiofemoral compartment of the knee. The patient-specific femoral and tibial components and single-use cutting quides are manufactured from CAD and CAM files generated from Bodycad software, which are based on MRI or CT images of the patient's knee and input from the surgeon. The BUKS is for cemented use only and is sterilized by gamma radiation.
The subject of this 510(k) notification is a line extension and design update that includes a new tibial baseplate that is compatible with the BUKS system (K163700, K181302) and instruments that are compatible with the new tibial baseplate.
Materials: Wrought Cobalt-28Chromium-6Molybdenum Alloy (CoCrMo; ASTM F1537-11) for the femoral component and screw, wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (Ti6Al4V ELI; ASTM F136-13) for the tibial baseplate, locking pin, and screw, Ultra-High-Molecular-Weight Polyethylene (UHMWPE; F648-14) for the tibial insert.
E. INTENDED USE
The patient-specific Bodycad Unicompartmental Knee System (Bodycad UKS) is indicated for unicompartmental knee arthroplasty (UKA) in patients with advanced knee osteoarthritis (OA) of the medial compartment with evidence of adequate healthy bone to support the implanted components. Candidates for unicompartmental knee replacement include those with:
- joint impairment due to osteoarthritis or traumatic arthritis of the knee,
- varus deformity of the knee, and ●
- as an alternative to tibial osteotomy in patients with unicompartmental OA. .
The patient-specific Bodycad UKS components fit within an envelope of dimensions that are specific to each patient. The Bodycad UKS femoral component and tibial baseplate are intended for cemented fixation. A Bodycad screw must be used for fixation of the femoral component.
F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The BUKS described in this 510(k) notification has the same intended use and general technological features as the predicate devices cleared by FDA in K163700 and K181302 (BUKS). The design modifications to the tibial baseplate cleared in K163700 include: Reduced thickness of the base plate (UHMWPE inset sliding and upper rails, cement pocket, and baseplate), reduced diameter of the locking pin and corresponding reduction of the diameter of hole for locking pin, increased diameter and redesign of fixation posts, addition of a medial fixation fin, and elimination of the flange and screw-hole for ancillary fixation. Other design changes relative to BUKS components cleared in K163700 is a single-use instrument for preparation of the holes and slot for the new fixation posts and fin. Comparison of the design features of the new BUKS tibial baseplate with those of the original BUKS baseplate (K163700, K181302) and the ZUK reference device, and results of performance testing of the subject tibial base plate and tibial insert assembly have established substantial equivalence of the subject, predicate, and reference devices.
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G. PERFORMANCE DATA
The following tests were performed for establishing substantial equivalence of subject, predicate, and reference devices:
- . Tibial baseplate fatigue strength per 3-point bend method as described in ASTM F3140-17, Standard Test Method for Cyclic Fatique Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements, and ASTM F1800-12, Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements.
- Resistance to dislodgement of the polyethylene insert in both the as-manufactured and . post cyclic fatigue conditions.
- . Pull-out force for the locking pin at time-zero, as manufactured, and post cyclic fatigue.
- Surgeon-user validation, simulated surgeries with the new tibial baseplate, locking pin, . insert, and associated instruments.
The results of performance testing demonstrated substantial equivalence of the subject, predicate, and reference devices.
H. CONCLUSION
The subject components of this line extension to the BUKS are substantially equivalent and share the same intended use as the predicate BUKS cleared in K163700 and K181302, and the reference device (K033363).