Alians Elbow S

K261191 · Newclip Technics · HRS · Jul 8, 2026 · Orthopedic

Device Facts

• Record ID: K261191
• Device Name: Alians Elbow S
• Applicant: Newclip Technics
• Product Code: HRS · Orthopedic
• Decision Date: Jul 8, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The implants of the Alians Elbow range are dedicated to the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.

Device Story

Alians Elbow S is a metallic bone fixation system consisting of plates and screws; used for stabilization of fractures and osteotomies of distal humerus and proximal ulna in adults. Implants are manufactured from titanium alloy; provided sterile (gamma) or non-sterile for hospital-based steam sterilization. System functions via mechanical fixation of bone segments; surgical implantation performed by orthopedic surgeons in clinical/OR settings. Device provides structural support to facilitate bone healing. No software or electronic components involved.

Clinical Evidence

No clinical data. Bench testing only. Engineering analysis and mechanical testing performed per ASTM F382 (plates) and ASTM F543 (screws). Pullout strength assessed against FDA guidance for orthopedic non-spinal metallic bone screws.

Technological Characteristics

Materials: Titanium alloy Ti-6Al-4V ELI (ASTM F136, ISO 5832-3). Components: Bone plates and screws. Sterilization: Gamma or steam. Mechanical testing: ASTM F382 (plates), ASTM F543 (screws).

Indications for Use

Indicated for fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.

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

• Alians Elbow Locking Plating System (K152289)

Reference Devices

• Synthes LCP Distal Humerus 3.5mm plate (K033995)
• I.T.S. OLS Olecranon Locking Plates System (K052368)
• DePuy Synthes 2.7 mm / 3.5 mm Variable Angle LCP Elbow System (K120717 / K120070)
• DePuy Synthes Small Fragment LCP System (K031178)
• Newclip Technics S.A.S. Xpert Wrist (K213214)
• Newclip Technics S.A.S. Xpert Knee (K250155)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 8, 2026

Newclip Technics
% J.D. Webb
President
The OrthoMedix Group, Inc.
4313 W. 3800 S.
West Haven, Utah 84401

Re: K261191

Trade/Device Name: Alians Elbow S

Regulation Number: 21 CFR 888.3030

Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories

Regulatory Class: Class II

Product Code: HRS, HWC

Dated: April 10, 2026

Received: April 13, 2026

Dear J.D. Webb:

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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 Management System Regulation (QMSR) (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

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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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,

CHRISTOPHER FERREIRA -S

Christopher Ferreira, M.S.

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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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261191 | ? |
| Please provide the device trade name(s). | | ? |
| Alians Elbow S | | |
| Please provide your Indications for Use below. | | ? |
| The implants of the Alians Elbow range are dedicated to the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |

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NEWCLIP-TECHNICS

K261191

## 510 (k) Summary - Alians Elbow S

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the Alians Elbow S range.

1. Submitter:

NEWCLIP TECHNICS

45 rue des Garottières

F-44115 Haute-Goulaine - France

Telephone: [phone]

Contact Person:

J.D. Webb

The OrthoMedix Group, Inc.

4313 W. 3800 S.

West Haven. UT 84401

Telephone: [phone]

2. Trade name:

Alians Elbow S

Common Name:

Plate, Fixation, Bone / Screw, Fixation, bone

Product code:

HRS - Plate, Fixation, Bone

HWC - Screw, Fixation, Bone

Classification Name:

Single/multiple component metallic bone fixation appliances and accessories. (21 CFR part. 888.3030)

Smooth or threaded metallic bone fixation fastener.(21 CFR part. 888.3040)

3. Primary predicate or legally marketed devices which are substantially equivalent:

NEWCLIP TECHNICS S.A.S. Alians Elbow Locking Plating System (K152289)

Reference predicate or legally marketed devices which are substantially equivalent:

- Synthes LCP Distal Humerus 3.5mm plate (K033995)
- I.T.S. OLS Olecranon Locking Plates System (K052368)
- DePuy Synthes 2.7 mm / 3.5 mm Variable Angle LCP Elbow System (K120717 / K120070)
- DePuy Synthes Small Fragment LCP System (K031178)
- Newclip Technics S.A.S. Xpert Wrist (K213214)
- Newclip Technics S.A.S. Alians Elbow Locking Plating System (K152289)
- Newclip Technics S.A.S. Xpert Knee (K250155)

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NEWCLIP-TECHNICS

# 4. Description of the device:

The Alians Elbow S range consists of plates and screws designed for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.

The plates and screws of the Alians Elbow S range will be provided sterile by gamma sterilization or non sterile for sterilization by health care professionals prior to use.

The instruments of the Alians Elbow S will be provided non sterile for sterilization by health care professionals prior to use.

# Materials:

Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3).

# Function:

The implants of the Alians Elbow range are dedicated to the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.

# 5. Technological characteristics and substantial equivalence

The Alians Elbow S range has the same or similar technological characteristics of the predicate device

# 6. Indication for use:

The implants of the Alians Elbow range are dedicated to the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.

# 7. Summary of the technological characteristics compared to predicate

Indication for use

The Alians Elbow S indications for use are the same as for the predicate devices.

Material

The Alians Elbow S range uses the same material as the primary predicate devices.

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# Design

The Alians Elbow S range and the predicates are substantially equivalent in terms of shape, and operating principles.

# Sizes

The Alians Elbow S range and the predicates are substantially equivalent in their dimensions.

# 8. Non-clinical Test Summary:

The following tests were conducted:

- Engineering analysis and comparative static and dynamic tests were performed on the plates, according to ASTM F382
- Engineering analysis regarding pullout strength and comparative torsional test were performed on the screws. The torsional and driving torque tests were following ASTM F543 and the pullout strength test followed the FDA guidance Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway-2020. The pullout strength test is an assessment of the axial pullout strength using the Chapman equation. The screws must have a pullout strength at least equivalent to the value given in the FDA guidance for the corresponding standard screws.

The analysis showed that the Alians Elbow S range is substantially equivalent to cleared predicates.

# 9. Clinical Test Summary:

No clinical studies were performed.

# 10. Conclusions Non-clinical and clinical:

The Alians Elbow S range is as safe, as effective, and performs as well or better than the legally marketed device identified above.

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