The Injection Pin, is indicated for fractures caused by severe osteoporosis, trauma, and tumors of the thoracic/lumbar spine from T9-L5. Injection Pin is indicated for use in combination with PMMA bone cement (Teknimed F200) for the treatment of fractures caused by trauma, osteoporosis, or turnors in the thoracic/lumbar spine from T9-L5.

Device Description

The Injection Pin is a single piece of Titanium alloy (Ti 6Al 4V) that complies with ISO 5832-3 and ASTM F136. It is a fenestrated screw that is cannulated along its entire length, with lateral holes along the body that do not interfere or affect the threads. The spherical head of the screw has an internal hexagon for firm coupling with the insertion screwdriver (REF IPST0007).

The Injection Pin implant is a medical device to be placed in the thoracolumbar region through a minimally invasive procedure. This device being cannulated and fenestrated permits the use, when applicable, for the introduction of approved PMMA (Teknimed F20®). It is available in both 5 and 6mm diameters and in lengths 31-61mm in 3mm increments.

The Injection Pin is easily seen Intra-Operatively as well as post-Op with good visualization.

AI/ML Overview

The SLK Ortho LLC Injection Pin (K221697) is a fenestrated screw made of Titanium alloy (Ti 6Al 4V) intended for use in combination with PMMA bone cement (Teknimed F20®) to treat fractures in the thoracic/lumbar spine (T9-L5) caused by severe osteoporosis, trauma, or tumors. The device's substantial equivalence to the predicate device, Hyprevention SAS V-STRUT© (K191709), was established through various performance tests.

Here's an analysis of the acceptance criteria and the supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list "acceptance criteria" in a numerical or pass/fail format for the Injection Pin device. However, the performance data presented is used to demonstrate substantial equivalence to the predicate device, V-STRUT©. The implicit acceptance criterion is that the Injection Pin exhibits substantially equivalent safety, effectiveness, and performance to the predicate device.

Test Category	Acceptance Criteria (Implicit)	Reported Device Performance (Injection Pin)
Biomechanical	Demonstrates substantially equivalent biomechanical behavior to the predicate device (V-STRUT©).	Mechanical testing (bending and torsional tests) was performed at the Polytechnic University of Milan, Dept. of Structural Engineering, applying worst-case loading scenarios. Bone cement injection testing was conducted to verify compatibility and delivery capability with Teknimed F20® cement under worst-case conditions. In silico simulations at Politecnico di Milano were validated and performed for 4 different scenarios, comparing the Injection Pin with the predicate V-STRUT©. The in-silico approach was consistent with the biomechanical behavior of an osteoporotic vertebra after augmentation (force-displacement curves, stiffness, maximum forces). Result: The Injection Pin device demonstrated substantially equivalent biomechanical behavior to the predicate V-strut device.
Biocompatibility	Non-cytotoxic, non-pyrogenic, and residuals from sterilization within acceptable limits.	Tested to be non-cytotoxic according to ISO 10993-1 – PART 5. Tested to be non-pyrogenic according to ISO 10993-1. ETO and ECH residuals were performed after EO sterilization process. Comparison with "marketed device" Miniars Screws (K143596) was used to demonstrate the safety of the manufacturing process.
Sterility	STERILE with a sterility assurance level (SAL) of 10-6.	Provided STERILE to the end user. Sterilized by Ethylene Oxide in accordance with ISO 11135-1 with a SAL of 10-6. Single use only.
Shelf-life	Maintain integrity and sterility for a specified shelf-life.	Released with a maximum shelf-life of 5 years from the date of sterilization. Validation performed in compliance with UNI EN ISO 11607-1:2009, UNI EN ISO 11607-2:2006, UNI EN 868:2009 (relevant sections), ASTM F 1980-07:2011, ASTM F 1608-00, ASTM F 1929-98, ASTM F 1886/ F 1886-M.

2. Sample Size Used for the Test Set and Data Provenance

Test Set (Biomechanical and Biocompatibility): The document does not specify a numerical sample size for the mechanical testing or in silico simulations beyond mentioning "worst-case loading scenario" and "4 different scenarios." For biocompatibility, it states "Injection Pin was tested" indicating that testing was performed on representative samples of the device.
Data Provenance:
- Biomechanical: Testing was conducted at the Polytechnic University of Milan, Dept. of Structural Engineering. In silico simulations were conducted in Labs of Politecnico di Milano.
- Biocompatibility: Testing performed on the Injection Pin device, likely in a laboratory setting.
Retrospective or Prospective: The testing described appears to be prospective, specifically designed to evaluate the performance of the Injection Pin device for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This type of information is generally not applicable to the non-clinical performance studies (biomechanical, biocompatibility, sterility, shelf-life) used for the Injection Pin. These studies evaluate the physical and biological characteristics of the device itself rather than interpretation of clinical images or patient data by human experts. The "ground truth" for these tests is based on established scientific principles, engineering standards (e.g., ISO, ASTM), and laboratory methodologies.

4. Adjudication Method for the Test Set

Not applicable, as this refers to adjudication by experts for clinical data interpretation, which is not described here. The evaluation involves laboratory testing against established specifications and comparison to a predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through non-clinical performance data (biomechanical, biocompatibility, sterility, shelf-life) in comparison to a predicate device, rather than a clinical trial involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies conducted (biomechanical, biocompatibility, sterility, shelf-life) are essentially "standalone" in nature, as they evaluate the device itself and its intrinsic properties without human-in-the-loop performance in a clinical setting. The in silico simulations are also a form of standalone evaluation.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical studies is:

Biomechanical: Defined by established engineering principles, material science properties, mechanical loads, and the performance characteristics of the legally marketed predicate device (V-STRUT©).
Biocompatibility: Based on established international standards (ISO 10993-1 parts 5 and ETO/ECH residual limits) and comparisons to a marketed device (Miniars Screws K143596).
Sterility: Defined by a Sterility Assurance Level (SAL) of 10-6 and adherence to ISO 11135-1.
Shelf-life: Defined by compliance with packaging and aging standards (e.g., UNI EN ISO 11607, ASTM F 1980-07).

8. The Sample Size for the Training Set

Not applicable. There is no information about a "training set" as this device assessment relies on non-clinical performance testing and in silico simulation for substantial equivalence, not machine learning or AI algorithm development that would involve training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set described in the provided document.

Summary

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March 3, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a square and the name in a sans-serif font.

SLK Ortho LLC Lawrence Kluge COO 5883 RFD Long Grove, Illinois 60047

Re: K221697

Trade/Device Name: Injection Pin Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: NDN, LOD Dated: January 25, 2023 Received: January 26, 2023

Dear Lawrence Kluge:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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,

Sara S. Thompson -S

For

Laura C. Rose, Ph.D. 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K221697

Device Name Injection Pin

Indications for Use (Describe)

Indication

Type of Use (Select one or both, as applicable)

Residential Use (Part 61 CFR 901 Subpart B)	Commercial Use (61 CFR 901 Subpart C)
---------------------------------------------	---------------------------------------

| | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Date last revision: March 3, 2023

I. SUBMITTER

SLK ORTHO LLC 5883 RFD Long Grove, IL 60047 Phone: (847) 630-1818 Email: SLK1818@aol.com Small Business Decision Number: SBD228450 FDA User Fee Organization Number: 664743

Official Correspondent

Lawrence Kluge SLK ORTHO LLC 5883 KED Long Grove, IL 60047 Phone: (847) 630-1818 Email: SLK1818@aol.com

Establishment Number

Small Business Decision Number: SBD228450 FDA User Fee Organization Number: 664743

II. DEVICE

Name of Device: Injection Pin Common/Usual Name: Injection Pin (Titanium Fenestrated Screw) Device Classification: Class II Regulation Number: 21 CFR 888.3027 Device Product Codes: NDN LOD

III. PREDICATE DEVICE

Reference Device:

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F20® (FDA registration number: K103433), Miniars Screw (FDA registration number K143596)

IV. DEVICE DESCRIPTION

The Injection Pin is easily seen Intra-Operatively as well as post-Op with good visualization.

V. INDICATIONS FOR USE

The Injection Pin is indicated for fractures caused by severe osteoporosis, trauma, and tumors of the thoracic/lumbar spine from T9-L5. Injection Pin is indicated for use in combination with PMMA bone cement (Teknimed F20®) for the treatment of fractures caused by trauma, osteoporosis, or tumors in the thoracic/lumbar spine from T9-L5.

COMPARISON	INJECTION PIN	V STRUT©
CLASSIFICATION	CLASS II	CLASS II
PICTURES	Image: Injection Pin	Image: V Strut
REGULATION	21 CFR 888.3027	21 CFR 888.3027
PRODUCT CODE	NDN, LOD	NDN, LOD
INDICATIONS	Indicated for use in fractures caused by severeosteoporosis, trauma, and tumors of thethoracic/lumbar spine from T9-L5. Indicated foruse in combination with PMMA bone cement(Teknimed F20®).	Indicated for use in combination withPMMA bone cement (Teknimed F20®) forthe treatment of fractures caused bytrauma, osteoporosis, or tumors in thethoracic/lumbar spine from T9-L5.
IMPLANT MATERIAL	Titanium alloy (Ti 6Al 4V) that complies with ISO5832-3 and ASTM F136.	PEEK-OPTIMA™ Polymer LT1(ASTM F2026) Tantalum markers.
IMPLANT SIZES	Dia. 5.0/6.0mm in lengths 31-61mm (3mm inc)	Pedicle access diameter: 5 mmStacked spiral diameter: 20 mmHeight: up to 15 mm
SINGLE USE	Yes	Yes
STERILE	Yes	Yes
CANNULATED	Yes	Yes
Instruments	Injection Pin Screwdriver	V-Strut Instrumentation kit

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE

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VII. PERFORMANCE DATA

Biomechanical

According to EN ISO 14602:2011 (ISO 14602:2010), intended uses are summarized in the following:

fracture treatment of T9-L5 vertebras.
tumor treatment of T9-L5 vertebras.

The device Injection Pin is intended in association with PMMA (Teknimed F20®) bone cement.

The Injection Pin device was subjected to mechanical testing and simulations. Injection Pin was tested at the Polytechnic University of Milan, Dept. of Structural Engineering Bending and torsional tests was performed applying the worst-case loading scenario.

Bone cement injection testing was conducted to verify that the injection pin is compatible with, and capable of, delivering Teknimed F20® cement under worst-case conditions.

In silico simulation in Labs of Politecnico di Milano was validated to perform 4 different scenarios in comparison with predicate device V-Strut. The in-silico approach was consistent with the biomechanical behavior of a representative osteoporotic vertebra after augmentation according to different force-displacement curves, stiffness, and maximum forces. The Injection Pin device demonstrated substantially equivalent biomechanical behavior to the predicate V-strut device.

Biocompatibility

Biocompatibility testing was conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." Injection Pin was tested to be non-cytotoxic according to ISO 10993-1 – PART 5 Injection Pin was tested to be non-pyrogenic according to ISO 10993-1 ETO and ECH residual were performed after EO sterilization process. Comparison with "marketed device" Miniars Screws (K143596) to demonstrate the safety of manufacturing process.

Sterility

Injection Pin is provided STERILE to the end user. This device is for single use only. Each device is sterilized by Ethylene Oxide in accordance with ISO 11135-1 Level (SAL) of 10-6

Shelf-life

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Injection Pin is released with a maximum shelf-life of 5 years from the date of sterilization. The validation was performed in compliance with the standard UNI EN ISO 11607-1:2009, UNI EN ISO 11607-2:2006, UNI EN 868:2009 (relevant sections), ASTM F 1980-07:2011, ASTM F 1608-00, ASTM F 1929-98, ASTM F 1886/ F 1886-M.

VIII. SUBSTANTIAL EQUIVALENCE CONCLUSION STATEMENT

INJECTION PIN Implant (Ti 6AL 4V) compared to the predicate device V-STRUT© has demonstrated safety, effectiveness and performance as intended. Thus, a conclusion of substantial equivalence to the predicate device is supported in this submission.

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”