K Number
K211883
Device Name
QUANTUM® Patient Specific Instrumentation (PSI) System
Manufacturer
Date Cleared
2021-08-11

(51 days)

Product Code
Regulation Number
888.3110
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 positioning of 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 Description
The QUANTUM® Patient Specific Instrumentation (PSI) system subject of this submission consists of: • QUANTUM® patient specific instrumentation (PSI) and reusable instruments: - QUANTUM® patient specific tibial and talar guides; - QUANTUM® reusable instruments; - QUANTUM® patient specific tibial and talar bone models; • ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software. The QUANTUM® PSI system is to be used with the given QUANTUM® Total Ankle Prosthesis (K191380) and their cleared indication for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. QUANTUM® PSI guides are single use instruments designed using the dedicated ORTHO-PLANIFY TAR planning software, in correlation with a pre-operative surgical plan validated by the surgeon. They fit the anatomy of the specific patient's distal tibia and proximal talus.
More Information

No
The summary describes a pre-operative planning software and patient-specific instrumentation based on standard imaging and surgeon validation, with no mention of AI or ML algorithms for image analysis, planning, or guide design.

No.
The device is an orthopedic instrument system used to assist in the positioning of instrumentation for total ankle replacement implantation; it does not directly treat a disease or condition.

No

The device, In2Bones PSI, is described as an orthopaedic instrument system and surgical planning software used to assist in the positioning of instrumentation for total ankle replacement implantation. Its function is to guide the surgeon in marking bone for cutting and previewing implant components, based on pre-operative imaging. It does not perform a diagnostic function of identifying or determining the nature or cause of a disease or condition; rather, it is a tool for surgical planning and execution.

No

The device description explicitly includes physical components like "patient specific tibial and talar guides" and "reusable instruments," in addition to the software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
  • Device Function: The In2Bones PSI system and TAR Planning software are described as orthopaedic instruments and software used to assist in the surgical planning and positioning of instruments for Total Ankle Replacement surgery. They utilize patient imaging data (X-rays and CT-scans) to create patient-specific guides and plan the surgical procedure.
  • Lack of Specimen Analysis: The device does not involve the collection, preparation, or analysis of any biological specimens from the patient. Its function is entirely focused on surgical planning and guidance based on anatomical imaging.

Therefore, the device falls under the category of surgical planning and instrumentation systems, not In Vitro Diagnostics.

N/A

Intended Use / Indications for 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 positioning of 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.

Product codes

HSN, OYK

Device Description

The QUANTUM® Patient Specific Instrumentation (PSI) system subject of this submission consists of:
• QUANTUM® patient specific instrumentation (PSI) and reusable instruments:

  • QUANTUM® patient specific tibial and talar guides;
  • QUANTUM® reusable instruments;
  • QUANTUM® patient specific tibial and talar bone models;
    • ORTHO-PLANIFY Total Ankle Replacement (TAR) planning software.

The QUANTUM® PSI system is to be used with the given QUANTUM® Total Ankle Prosthesis (K191380) and their cleared indication for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
QUANTUM® PSI guides are single use instruments designed using the dedicated ORTHO-PLANIFY TAR planning software, in correlation with a pre-operative surgical plan validated by the surgeon. They fit the anatomy of the specific patient's distal tibia and proximal talus.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-rays and CT-scan

Anatomical Site

distal tibia and proximal talus

Indicated Patient Age Range

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical performance data were included in the 510(k) submission demonstrating that QUANTUM PSI system and its associated ORTHO-PLANIFY TAR planning software has been validated for its intended use and demonstrating substantial equivalence to the predicate device. Non-clinical testing included software verification and validation, repeatability testing and cadaveric validations. Tests results demonstrate that QUANTUM PSI system and its associated ORTHO-PLANIFY TAR planning software are safe and effective for their intended use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K162795, K170968

Reference Device(s)

K191380

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
Classification. Class II.

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August 11, 2021

Image /page/0/Picture/1 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.

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

Re: K211883

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 Code: HSN, OYK Dated: June 16, 2021 Received: June 21, 2021

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ting Song, Ph.D., R.A.C. 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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K211883

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 positioning of 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)
⊠ Prescription Use (Part 21 CFR 801 Subpart D)□ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY For QUANTUM® Patient Specific Instrumentation (PSI) System

| Sponsor
identification | In2Bones SAS
28 chemin du Petit Bois
69130 Ecully – France
Phone: +33.4.72.29.26.26
Fax: +33.4.72.29.26.29 |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
registration
number | 3010470577 |
| Date of
preparation | August 11, 2021 |
| Contact person | Christine SCIFERT, MS, MEM
In2BonesUSA
6000 Poplar Avenue, suite 115
Memphis, TN 38119
Cell: 901-831-8053
Email: cscifert@i2b-usa.com |
| Proprietary
Name | QUANTUM® Patient Specific Instrumentation (PSI) System |
| Common name | PSI System |
| Device
classification
regulation | 21 CFR 888.3110
Class II |
| Device Product
Code and Panel | Orthopedic
HSN: Prosthesis, Ankle, Semi-Constrained, Cemented,
Metal/Polymer
OYK: Ankle Arthroplasty Implantation System |
| Device
Description | The QUANTUM® Patient Specific Instrumentation (PSI) system
subject of this submission consists of:
• QUANTUM® patient specific instrumentation (PSI) and reusable
instruments:

  • QUANTUM® patient specific tibial and talar guides;
  • QUANTUM® reusable instruments;
  • QUANTUM® patient specific tibial and talar bone models;
    • ORTHO-PLANIFY Total Ankle Replacement (TAR) planning
    software. |
    | | The QUANTUM® PSI system is to be used with the given
    QUANTUM® Total Ankle Prosthesis (K191380) and their cleared
    indication for use, provided that anatomic landmarks necessary for
    alignment and positioning of the implant are identifiable on patient
    imaging scans.
    QUANTUM® PSI guides are single use instruments designed using
    the dedicated ORTHO-PLANIFY TAR planning software, in
    correlation with a pre-operative surgical plan validated by the
    surgeon. They fit the anatomy of the specific patient's distal tibia and
    proximal talus. |
    | Predicate
    Devices | Primary predicate:
    PROPHECY INVISION Pre-operative Navigation
    System
    (K162795 & K170968), Wright Medical Technology Inc.
    Reference predicate:
    QUANTUM® Total Ankle Prosthesis (K191380), In2Bones SAS. |
    | Indications for
    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
    positioning of 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. |
    | | 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. |
    | Technological
    characteristics: | The provided detailed comparison demonstrates the QUANTUM PSI
    system and its associated ORTHO-PLANIFY TAR planning
    software is substantially equivalent in intended use, design, operating
    principles, materials and performance characteristics to the predicate
    device cleared in K162795 and K170968. The differences in
    technological characteristics do not raise new questions of safety and
    effectiveness. |
    | Performance
    Data | Non-clinical performance data were included in the 510(k)
    submission demonstrating that QUANTUM PSI system and its
    associated ORTHO-PLANIFY TAR planning software has been
    validated for its intended use and demonstrating substantial
    equivalence to the predicate device. Non-clinical testing included
    software verification and validation, repeatability testing and
    cadaveric validations. Tests results demonstrate that QUANTUM PSI
    system and its associated ORTHO-PLANIFY TAR planning
    software are safe and effective for their intended use. |
    | CONCLUSION | Based on the comparison of indications for use and technological
    characteristics and the results of the testing performed, the
    QUANTUM® PSI System is substantially equivalent to the
    predicate device identified in the 510(k) submission. |

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TAR Planning software: The TAR Planning Software is a preoperative surgical planning software intended to be used with In2Bones QUANTUM® Patient Specific Instrumentation (PSI)