Newclip Patient-matched instrumentation non sterile PSI

K250767 · Newclip Technics · PBF · Oct 1, 2025 · Orthopedic

Device Facts

• Record ID: K250767
• Device Name: Newclip Patient-matched instrumentation non sterile PSI
• Applicant: Newclip Technics
• Product Code: PBF · Orthopedic
• Decision Date: Oct 1, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in Distal Tibial Medial Opening or Closing Wedge Osteotomy, Distal Tibial Lateral Closing Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient’s radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip Activmotion S DTO Range.

Device Story

Patient-specific instrument (PSI) guides; assist pre-operative planning and guide surgical instruments (drilling/cutting) for distal tibial osteotomies. Input: patient CT images. Transformation: additive manufacturing (AM) process creates guides matching patient anatomy. Output: physical surgical guides. Used in clinical setting by surgeons. Guides facilitate implantation of Newclip Activmotion S DTO Range devices. Benefit: improved surgical accuracy, stability, and preservation of hinge during osteotomy procedures.

Clinical Evidence

Bench testing only. V&V included segmentation process analysis, worst-case design/manufacturing analysis, and simulated surgeries in sawbones and cadavers. Studies involved surgeons of varying experience levels (novice, intermediate, expert). Results confirmed guides were positioned without issue, planned corrections were achieved, mechanical stability was maintained, and hinge was preserved. Performance metrics demonstrated equivalence to predicate.

Technological Characteristics

Material: Polyamide (PA2200). Manufacturing: Additive manufacturing (AM). Form factor: Patient-specific surgical guides. Connectivity: None. Sterilization: Provided non-sterile. Software: Used for patient-specific design/segmentation.

Indications for Use

Indicated for adult patients undergoing Distal Tibial Medial Opening or Closing Wedge Osteotomy or Distal Tibial Lateral Closing Osteotomy, where anatomic landmarks are identifiable via CT imaging.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Newclip Patient-matched instrumentation non sterile PSI (K243912)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

October 1, 2025

NewClip Technics
% Robert Poggie
President
BioVera, Inc.
65 Promenade Saint Louis
Notre-Dame-de-L'Ile-Perrot, QC J7W3J6
Canada

Re: K250767
Trade/Device Name: Newclip Patient-matched instrumentation non sterile PSI
Regulation Number: 21 CFR 888.3030
Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories
Regulatory Class: Class II
Product Code: PBF
Dated: March 12, 2025
Received: March 13, 2025

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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assistance/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,

Shumaya Ali -S
Shumaya Ali, M.P.H.
Assistant Director
DHT6C: Division of Restorative,
Repair, and Trauma Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K250767 | |
| Device Name | |
| Newclip Patient-matched instrumentation non sterile PSI | |
| Indications for Use (Describe) | |
| The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in Distal Tibial Medial Opening or Closing Wedge Osteotomy, Distal Tibial Lateral Closing Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient’s radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip Activmotion S DTO Range. | |
| 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 [e-mail] | |
| "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." | |

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# 510(k) Summary for K250767
Newclip Patient-matched instrumentation non sterile PSI

In accordance with 21 CFR 807.92, the following information is a 510(k) Summary for Newclip's Patient-matched instrumentation non sterile PSI.

## A. SUBMITTER INFORMATION

**Sponsor Name:** NEWCLIP TECHNICS

**Sponsor Address:** P.A. de la Lande Saint Martin, 45 rue des Garottières, F-44115 Haute-Goulaine, FRANCE

**Submitter Name:** BioVera, Inc.

**Submitter Address:** 65 Promenade Saint-Louis, Notre-Dame-De-L’Ile-Perrot, QC, J7W 3J6, CANADA

**Contact Person:** Robert A. Poggie, PhD

**Phone & Email:** [phone] & [e-mail]

**Date of Preparation:** September 29, 2025

## B. DEVICE IDENTIFICATION

**Device Trade Name:** Newclip Patient-matched instrumentation non sterile PSI

**Device Common Name:** Orthopaedic Surgical Planning and Instrument Guides

**Classification Code:** PBF

**Classification Name:** Single/multiple component metallic bone fixation appliances and accessories

**Classification Panel:** Orthopedic

**Regulation:** 21 CFR 888.3030

## C. PREDICATE DEVICE

**K243912** Newclip Patient-matched instrumentation non sterile PSI

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# D. DEVICE DESCRIPTION

Newclip Patient-matched instrumentation non sterile PSI are patient specific instrument (PSI) guides intended to assist in pre-operative planning and/or in guiding the marking of bone and/or surgical instruments in non-acute, non-joint replacing osteotomies about the knee and distal tibia. The PSI Guides are surgical drilling and cutting instruments that are designed to match the patient's anatomy. The PSI guides are additively manufactured, are single-use devices, and provided clean, nonsterile to the end-user. The purpose of this 510(k) is to obtain FDA clearance for PSI Guides for distal tibial osteotomies and facilitate implantation of Newclip Activmotion S DTO Range devices that were 510(k) cleared by the US FDA.

Material: Polyamide (PA2200).

# E. INDICATIONS FOR USE

The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in Distal Tibial Medial Opening or Closing Wedge Osteotomy, Distal Tibial Lateral Closing Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip Activmotion S DTO Range.

# F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The Newclip Patient-matched instrumentation non sterile PSI has the same or similar technological characteristics and indicated uses as the predicate device with the exception of the subject device being used for osteotomies of the distal tibia and the predicate device being used for osteotomies about the knee.

Target population: The Newclip Patient-matched instrumentation non sterile PSI are intended for the same subset of the target population (adults) of the predicate device.

Material: The Newclip Patient-matched instrumentation non sterile PSI uses the same additively manufactured (AM) Polyamide material as the predicate device.

Manufacturing method: The Newclip Patient-matched instrumentation non sterile PSI are manufactured using the same AM method as the predicate device.

Imagery technique: The Newclip Patient-matched instrumentation non sterile PSI uses the same image technique (CT) as the predicate device (K243912).

Surgeon training and documentation: The training of US surgeons on the subject PSI guides is performed with similar presentation materials and training-form cleared in K243912.

The subject and predicate devices are indicated as surgical instruments to assist in preoperative planning and/or in guiding surgical instruments when the anatomic landmarks

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necessary for pre-operative planning are clearly identified on the patient's radiographic images (i.e. computed tomography (CT)). The primary predicate device are PSI guides for opening femoral and tibial, closing-femoral, and de-rotation wedge osteotomies, and closing-tibial lateral and anterior approach osteotomies about the knee whereas the subject device are PSI guides for opening and closing wedge distal tibial osteotomies. The subject device is designed to be compatible with implants from the Newclip Activmotion S DTO Range that were previously 510(k) cleared by the US FDA. Comparison of the technological characteristics and indicated use of the subject and predicate devices demonstrate that the subject device is substantially equivalent to the predicate device.

## G. PERFORMANCE DATA

Verification & validation (V&V) work for the subject device included: (1) analysis of the segmentation process and identification of worst case parameters, (2) a worst-case analysis for design and manufacturing of the PSI guides that included intra-operator variability, and (3) worst-case analyses of the usability, stability, and accuracy of fit and correction of the subject PSI guides in simulated sawbones and cadaver surgeries.

(1) The results of segmentation V&V work for the subject device indicated no new worst-case relative to the segmentation process for the predicate device.

(2) The V&V work for manufacturing PSI guides for distal tibial osteotomies was performed by three NewClip operators with differing levels of experience applied to worst-case guide design and manufacture followed by comparison of dimensions, design, correction, and placement. The results of the V&V work demonstrated similar precision and accuracy of design, correction, and manufacture for the subject and predicate PSI guides.

(3) Simulated surgeries of worst-case, subject PSI guides in sawbones and cadavers were performed in two separate studies by several surgeons with varying level of experience (novice, intermediate, expert) using similar laboratory techniques, performance measures, and criteria reported in K243912 and discussed with FDA in Q251405. The results of the cadaver studies showed the subject PSI guides to be positioned without issue for opening and closing wedge distal tibial osteotomies, that the planned corrections were achieved, that the guides were mechanically stable throughout use, and that the hinge was preserved.

The results of the V&V work demonstrated that the subject device are as safe and effective as the predicate device described in K243912.

## H. CONCLUSION

The information in this 510(k) shows the Newclip Patient-matched instrumentation non sterile PSI for distal tibial osteotomies to be substantially equivalent to the legally marketed predicate device for osteotomies about the knee.