Who is the manufacturer of QUANTUM® Patient Specific Instrumentation (PSI) System?

In2bones Sas filed the 510(k) submission for QUANTUM® Patient Specific Instrumentation (PSI) System (K211883).

What is the FDA product code for QUANTUM® Patient Specific Instrumentation (PSI) System?

HSN. It is classified under 21 CFR 888.3110 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for QUANTUM® Patient Specific Instrumentation (PSI) System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for QUANTUM® Patient Specific Instrumentation (PSI) System?

PROPHECY INVISION Pre-operative Navigation System (K162795 & K170968).

Who can help prepare an FDA 510(k) submission like QUANTUM® Patient Specific Instrumentation (PSI) System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

QUANTUM® Patient Specific Instrumentation (PSI) System

K211883 · In2bones Sas · HSN · Aug 11, 2021 · Orthopedic

Device Facts

Record ID	K211883
Device Name	QUANTUM® Patient Specific Instrumentation (PSI) System
Applicant	In2bones Sas
Product Code	HSN · Orthopedic
Decision Date	Aug 11, 2021
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 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 Story

System comprises patient-specific instrumentation (PSI) guides, reusable instruments, bone models, and ORTHO-PLANIFY TAR planning software. Input: patient X-rays and CT-scan images. Surgeon uses software to perform preoperative planning, validate implant positioning, and design patient-specific guides based on distal tibia and proximal talus anatomy. Output: 3D-printed single-use guides used intraoperatively to assist in positioning instrumentation for bone cuts and drilling. Used in clinical settings by orthopedic surgeons. Guides ensure accurate alignment of QUANTUM® Total Ankle Prosthesis components. Benefits include improved surgical precision and implant placement accuracy.

Clinical Evidence

Bench testing only. Included software verification and validation, repeatability testing, and cadaveric validations. No clinical data presented.

Technological Characteristics

System includes patient-specific guides and planning software. Guides are single-use, custom-manufactured to fit patient anatomy derived from CT/X-ray data. Software provides display and positioning tools for preoperative planning. No specific material standards or algorithm architecture details provided.

Indications for Use

Indicated for patients requiring Total Ankle Replacement (TAR) who meet QUANTUM® implant criteria and have available, protocol-compliant X-ray and CT-scan imaging.

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

PROPHECY INVISION Pre-operative Navigation System (K162795 & K170968)

Reference Devices

QUANTUM® Total Ankle Prosthesis (K191380)

Related Devices

K231699 — QUANTUM® Patient Specific Instrumentation (PSI) System · In2bones Sas · Apr 23, 2024
K230313 — QUANTUM Patient Specific Instrumentation (PSI) System · In2bones Sas · Apr 6, 2023
K241326 — Cadence Ankle PSI System · 3D Systems, Inc. · Aug 30, 2024
K193432 — Vantage PSI System · 3D Systems · Nov 9, 2020
K223326 — Axiom PSR System · Restor3D · Mar 30, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ 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) | | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *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 "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for IN2BONES. The logo is an oval shape with a gray background. The text "IN2BONES" is in white, with the "2" in orange. ## 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. | {4}------------------------------------------------ {5}------------------------------------------------ TAR Planning software: The TAR Planning Software is a preoperative surgical planning software intended to be used with In2Bones QUANTUM® Patient Specific Instrumentation (PSI)