QUANTUM Patient Specific Instrumentation (PSI) System

K230313 · In2bones Sas · HSN · Apr 6, 2023 · Orthopedic

Device Facts

• Record ID: K230313
• Device Name: QUANTUM Patient Specific Instrumentation (PSI) System
• Applicant: In2bones Sas
• Product Code: HSN · Orthopedic
• Decision Date: Apr 6, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3110
• Device Class: Class 2

Intended Use

In2Bones PSI: In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) is indicated as an orthopaedic instrument system to assist in the instrumentation positioning dedicated to In2Bones QUANTUM® Total Ankle Replacement implantation. In2Bones QUANTUM® PSI guides are compatible with QUANTUM® tibial tray, QUANTUM® tibial inlay, as well as standard and Flat-Cut QUANTUM® talar implants. PSI Guides are intended for single use only. PSI Guides are manufactured in correlation with a pre-operative planning validated by the surgeon on the TAR Planning Software and assist in the dedicated QUANTUM® instrumentation with which drillings or bone cuts will be performed. In2Bones QUANTUM® PSI guides are indicated for patient population fulfilling the QUANTUM® Total Ankle Replacement indications and for which X-rays and CT-scan images are available and compliant with imaging protocol provided by In2Bones. TAR Planning software: The TAR Planning Software is a preoperative surgical planning software intended to be used with In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides and QUANTUM® Total Ankle Replacement. TAR Planning Software allows the surgeon to use advanced display and positioning tools to guide the marking of bone before cutting and preview the total ankle replacement components intraoperatively, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient X-rays and imaging scans. X-rays and CT-scan are the accepted imaging modalities for these procedures.

Device Story

System comprises patient-specific tibial/talar guides, reusable instruments, and ORTHO-PLANIFY TAR planning software. Guides are single-use, custom-manufactured based on surgeon-validated pre-operative plans derived from patient CT/X-ray data. Surgeon uses software to visualize anatomy, mark bone, and preview implant positioning. Guides fit patient-specific distal tibia and proximal talus anatomy to assist in precise drilling and bone cuts during TAR surgery. System facilitates accurate implant alignment; benefits include improved surgical precision and procedural planning. Used in clinical settings by orthopedic surgeons.

Clinical Evidence

Bench testing only. Biocompatibility (ISO 10993) and sterilization (ISO 17665) validation performed to demonstrate substantial equivalence.

Technological Characteristics

Patient-specific guides manufactured to match patient anatomy; single-use. Software-driven design. Materials and design equivalent to K211883. Sterilization per ISO 17665. Biocompatibility per ISO 10993.

Indications for Use

Indicated for patients requiring Total Ankle Replacement (TAR) who meet the criteria for the QUANTUM® Total Ankle Replacement system and have available X-ray and CT-scan imaging compliant with In2Bones protocols.

Regulatory Classification

Identification

An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• QUANTUM® Patient Specific Instrumentation (PSI) System (K211883)

Reference Devices

• QUANTUM® Total Ankle Prosthesis (K191380)

Submission Summary (Full Text)

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April 6, 2023

Image /page/0/Picture/1 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

In2Bones SAS % Christine Scifert VP QA & RA In2Bones USA 6600 Poplar Ave, Suite 115 Memphis, Tennessee 38119

Re: K230313

Trade/Device Name: QUANTUM Patient Specific Instrumentation (PSI) System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Codes: HSN, OYK Dated: February 3, 2023 Received: February 6, 2023

Dear Christine Scifert:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Figure/5 description: The image shows the name "Peter G. Allen" in large, bold font, followed by "-S" on the next line. To the right of the name, there is text that reads "Digitally signed by Peter G. Allen -S Date: 2023.04.06 16:21:25 -04'00'". The text indicates that the document was digitally signed by Peter G. Allen on April 6, 2023, at 4:21:25 PM.

For:

[Vacant] 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)

K230313

### Device Name

QUANTUM® Patient Specific Instrumentation (PSI) System

## Indications for Use (Describe)

In2Bones PSI: In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides for Total Ankle Replacement (TAR) is indicated as an orthopaedic instrument system to assist in the instrumentation positioning dedicated to In2Bones QUANTUM® Total Ankle Replacement implantation. In2Bones QUANTUM® PSI guides are compatible with QUANTUM® tibial tray, QUANTUM® tibial inlay, as well as standard and Flat-Cut QUANTUM® talar implants.

PSI Guides are intended for single use only. PSI Guides are manufactured in correlation with a pre-operative planning validated by the surgeon on the TAR Planning Software and assist in the dedicated QUANTUM® instrumentation with which drillings or bone cuts will be performed. In2Bones QUANTUM® PSI guides are indicated for patient population fulfilling the QUANTUM® Total Ankle Replacement indications and for which X-rays and CT-scan images are available and compliant with imaging protocol provided by In2Bones.

TAR Planning software: The TAR Planning Software is a preoperative surgical planning software intended to be used with In2Bones QUANTUM® Patient Specific Instrumentation (PSI) Guides and QUANTUM® Total Ankle Replacement. TAR Planning Software allows the surgeon to use advanced display and positioning tools to guide the marking of bone before cutting and preview the total ankle replacement components intraoperatively, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient X-rays and imaging scans. X-rays and CT-scan are the accepted imaging modalities for these procedures.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><div>X</div><div>Prescription Use (Part 21 CFR 801 Subpart D)</div></div> | <div style="display:flex; align-items:center;"><div></div><div>Over-The-Counter Use (21 CFR 801 Subpart C)</div></div> |
| CONTINUE ON A SEPARATE PAGE IF NEEDED | |

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# 510(k) SUMMARY For QUANTUM® Patient Specific Instrumentation (PSI) System February 3, 2023

| Sponsor identification | In2Bones SAS<br>Sabina Ahaddad<br>28 chemin du Petit Bois<br>69130 Ecully – France<br>Phone: [phone]<br>Fax: [phone] |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment registration number | 3010470577 |
| Date of preparation | January 9, 2023 |
| Contact person | Christine Scifert<br>In2BonesUSA<br>6000 Poplar Avenue, Suite 115<br>Memphis, TN 38119<br>Cell: 901-831-8053<br>Email: [e-mail] |
| Proprietary Name | QUANTUM® Patient Specific Instrumentation (PSI) System |
| Common name | Ankle Arthroplasty Implantation System |
| Device classification regulation | 21 CFR 888.3110<br>Class II |
| Device Product Code and Panel | Orthopedic<br>HSN: Prosthesis, Ankle, Semi-Constrained, Cemented,<br>Metal/Polymer<br>OYK: Ankle Arthroplasty Implantation System |
| Device<br>Description | The previously cleared single use QUANTUM® Patient Specific<br>Instrumentation (PSI) system subject of this submission consists of:<br>• QUANTUM® patient specific instrumentation (PSI) and reusable<br>instruments:<br>- QUANTUM® patient specific tibial and talar guides;<br>- QUANTUM® reusable instruments;<br>- QUANTUM® patient specific tibial and talar bone models<br>(not medical devices);<br>• ORTHO-PLANIFY Total Ankle Replacement (TAR) planning<br>software. |
| | The QUANTUM® PSI system is to be used with the given<br>QUANTUM® Total Ankle Prosthesis (K191380) and their cleared<br>indication for use, provided that anatomic landmarks necessary for<br>alignment and positioning of the implant are identifiable on patient<br>imaging scans. |
| | QUANTUM® PSI guides are single use instruments designed using<br>the dedicated ORTHO-PLANIFY TAR planning software, in<br>correlation with a pre-operative surgical plan validated by the<br>surgeon. They fit the anatomy of the specific patient's distal tibia and<br>proximal talus. |
| | The scope of this submission is an addition of a manufacturer, slight<br>update to dimensions and raw material for the cut guides related to<br>the In2Bones QUANTUM® Patient Specific Instrumentation (PSI)<br>Guides for Total Ankle Replacement (TAR) previously cleared in<br>K211883. |
| Predicate<br>Devices | Primary predicate:<br>QUANTUM® Patient Specific Instrumentation (PSI) System<br>(K211883), In2Bones SAS |
| | Reference predicate:<br>QUANTUM® Total Ankle Prosthesis (K191380), In2Bones SAS. |
| Indications for<br>use: | In2Bones PSI: In2Bones QUANTUM® Patient Specific<br>Instrumentation (PSI) Guides for Total Ankle Replacement (TAR)<br>is indicated as an orthopaedic instrument system to assist in the<br>instrumentation positioning dedicated to In2Bones QUANTUM®<br>Total Ankle Replacement implantation. In2Bones QUANTUM®<br>PSI guides are compatible with QUANTUM® tibial tray,<br>QUANTUM® tibial inlay, as well as standard and Flat-Cut<br>QUANTUM® talar implants. |
| CONCLUSION | Based on the comparison of indications for use and technological<br>characteristics and the results of the testing performed, the<br>OUANTUM® PSI System is substantially equivalent to the<br>predicate device identified in the 510(k) submission. |
| Performance<br>Data | Non-clinical performance data were included in the 510(k)<br>Validations<br>submission.<br>equipment,<br>biocompatibility (ISO 10993) and sterilization (ISO 17665) were<br>conducted to demonstrate that the QUANTUM PSI system is<br>substantial equivalence to the predicate device. |
| Technological<br>characteristics: | The provided detailed comparison demonstrates the subject cut<br>guides for the QUANTUM PSI system are substantially equivalent in<br>intended use, design, operating principles, materials and performance<br>characteristics to the predicate device cleared in K211883. The<br>primary difference is an additional manufacturer for the cut guides. |
| | TAR Planning software: The TAR Planning Software is a<br>preoperative surgical planning software intended to be used with<br>In2Bones QUANTUM® Patient Specific Instrumentation (PSI)<br>Guides and QUANTUM® Total Ankle Replacement. TAR Planning<br>Software allows the surgeon to use advanced display and positioning<br>tools to guide the marking of bone before cutting and preview the<br>total ankle replacement components intraoperatively, provided that<br>anatomic landmarks necessary for alignment and positioning of the<br>implant are identifiable on patient X-rays and imaging scans. X-rays<br>and CT-scan are the accepted imaging modalities for these<br>procedures. |
| | PSI Guides are intended for single use only. PSI Guides are<br>manufactured in correlation with a pre-operative planning validated<br>by the surgeon on the TAR Planning Software and assist in the<br>positioning of the dedicated QUANTUM® instrumentation with<br>which drillings or bone cuts will be performed. In2Bones<br>QUANTUM® PSI guides are indicated for patient population<br>fulfilling the QUANTUM® Total Ankle Replacement indications<br>and for which X-rays and CT-scan images are available and<br>compliant with imaging protocol provided by In2Bones. |

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