The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is intended for use in skeletally mature patients for fracture fixation of small and long bones of the pelvis, and for sacroiliac joint fusion for patients suffering from sacroiliac joint disruptions and degenerative sacroiliitis.

Device Description

The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is designed for sacroiliac joint fusion in degenerative sacroiliitis, as well as for the fixation of small and long bone fractures in trauma cases. The screws are hollow-body threaded fusion devices with a self-tapping design, tapered tip, long pitch and dual thread, and a reverse cutting flute. They are cannulated to accept a Ø 3.2 mm guide wire. Sacroiliac joint screws are available in titanium with a rough Hydroxyapatite (HA) coating. Pelvic trauma screws are available in both full and partial thread designs in Titanium-6Aluminum-4Vanadium Extra Low Interstitial (Ti-6A1-4V ELI) and Stainless Steel. Washers are available in standard and favored designs. Radial windowed slots along the screw's body are intended to allow surrounding bone access to bone substitute.

AI/ML Overview

This document describes a 510(k) premarket notification for the "M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System." The information provided does not contain details about an AI/ML powered device, nor does it describe acceptance criteria and a study proving an AI/ML device meets those criteria.

Instead, this document is for a physical medical device (screws and plates for bone fixation) and focuses on demonstrating substantial equivalence to predicate devices through:

Comparison of technological characteristics: Comparing the new device's material, dimensions, design, and sterilization methods to existing, legally marketed devices.
Non-clinical performance testing: Referring to mechanical and material tests conducted according to established ASTM and ISO standards (e.g., ASTM F543-13 for bone screws, ISO 13779-3 for hydroxyapatite coating). These tests are typically for mechanical strength, biocompatibility, and material properties.
No clinical studies were conducted for this particular submission, as stated under "Clinical Studies."

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device based on the provided text. The document doesn't discuss AI model performance metrics like accuracy, sensitivity, or specificity, nor does it mention training/test sets, expert adjudication, or MRMC studies.

Summary

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Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Medacta International SA % Elizabeth Rose. MST. RAC Regulatory Affairs Manager Mapi USA. Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504

August 2, 2017

Re: K171595

Trade/Device Name: M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR, HWC, HTN Dated: July 21, 2017 Received: July 25, 2017

Dear Ms. Rose:

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. 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K171595

Device Name

M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System

Indications for Use (Describe)

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

I. Submitter

Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66

Contact Person: Stefano Baj, Regulatory Affairs Manager Date Prepared: May 30, 2017 Date Revised: August 1, 2017

DEVICE
Device Proprietary Name:	M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
Common or Usual Name:	Pelvic Joint Fixation
Classification Name:	Smooth or threaded metallic bone fixation fastener
Primary Product Code:	OUR
Secondary Product Code:	HWC, HTN
Regulation Number:	21 CFR 888.3040, 21 CFR 888.3030
Device Classification	ನ

TI Device

III. Predicate Device

Substantial equivalence is claimed to the following devices:

Primary Predicate: Synthes 6.5 mm Cannulated Screw (Also referred to as Synthes Cannulated Screws), K021932, Synthes (USA)

Additional Predicates:

Pelvic Trauma and Washers

Synthes 7.0/7.3 mm Cannulated Screws (Also referred to as Synthes Cannulated Screws), K962011, Synthes (USA)
Asnis III Cannulated Screw System, K000080, Howmedica Osteonics Corp.
Modification to Asnis III Cannulated Screw System, K024060, Howmedica Osteonics Corp.

Sacro-Iliac Joint Screws

SI-LOK Sacroiliac Joint Fixation System, K112028, Globus Medical, Inc. ●
SImmetry Sacroiliac Joint Fusion System. K130092, Zyga Technology, Inc. ●

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Reference Devices

Medacta Total Hip Prosthesis System Quadra H and R Femoral Stems, K082792, . Medacta International SA
Medacta Bipolar Head, K091967, Medacta International SA .

IV. Device Description

The purpose of this submission is to gain clearance for the new M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System. The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is designed for sacroiliac joint fusion in degenerative sacroiliitis, as well as for the fixation of small and long bone fractures in trauma cases.

The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System screws are hollow-body threaded fusion devices with a self-tapping design to facilitate screw insertion, with a tapered tip to aid in guidance through pilot hole. The long pitch and dual thread aid in accelerated screw insertion and removal. A reverse cutting flute is incorporated in the design to facilitate screw removal. The cannulated shaft accepts a Ø 3.2 mm guide wire.

The sacroiliac joint screws are available in titanium and coated with rough Hydroxyapatite (HA) to accommodate sacroiliac joint degeneration. The HA coating allows for biological fixation and potentially leads to arthrodesis. The pelvic trauma screws are available in both full and partial thread designs to aid in fixation in trauma cases. Thread lengths, in combination with the washer application, fit into bone fragments to allow for compression. Radial windowed slots along the screw's body are intended to allow surrounding bone access to the bone substitute used during insertion. Washers are available in both standard and favored designs. The favored design provides angles to accommodate higher angulation.

The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System: Sacroiliac Screws are manufactured with Titanium-6Aluminum-4Vanadium Extra Low Interstitial (Ti-6A1-4V ELI) and the surface treatment consists of an HA coating. The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System: Pelvic Trauma Screws and Washers are manufactured from both Titanium-4Vanadium Extra Low Interstitial (Ti-6Al-4V ELI) and Stainless Steel.

The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is similar to predicate devices Synthes' Cannulated Screws (K962011 and K021932), Howmedica's Asnis III Cannulated Screw System (K000080 and K024060), Globus's SI-LOK Sacroiliac Joint Fixation System (K112028) and Zyga's SImmetry Sacroiliac Joint Fusion System (K130092).

V. Indications for Use

VI. Comparison of Technological Characteristics

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The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System and the predicate devices share the following characteristics:

Indications for Use .
Materials of Construction ●
Design ●
Sterile ●
Coating
Threaded ●
Thread Design
Device Usage

The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is technologically different from the predicate devices as follows:

. Diameters
Lengths .

The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System components are manufactured from Titanium-6Aluminum-4Vanadium Extra Low Interstitial Alloy (ISO 5832-3:1996 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium-6Aluminum-4Vanadium Alloy. ASTM F136-13 Standard Specification For Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy For Surgical Implant Applications) and/or Stainless Steel (ISO 5832-1 Fifth Edition 2016-07-15 Implants For Surgery-Metallic Materials-Part 1: Wrought Stainless Steel and ASTM F138-13 Standard Specification For Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire For Surgical Implants).

These materials have been reviewed in the predicate devices' 510(k) submissions Synthes' Cannulated Screws (K962011 and K021932), Howmedica's Asnis III Cannulated Screw System (K000080 and K024060), Globus's SI-LOK Sacroiliac Joint Fixation System (K112028) and Zyga's SImmetry Sacroiliac Joint Fusion System (K130092).

The Hydroxyapatite "Osprovit®" coating used on the M.U.S.T. Sacral Iliac Screws is provided by Eurocoating S.p.A. The Hydroxyapatite "Osprovit®" coating with a titanium alloy substrate was previously reviewed as part of Medacta's submission Total Hip Prosthesis System - Quadra H and R Femoral Stems (K082792).

Due to the extensive history of use in currently marketed medical devices made of the same material, following recognized standards, and following identical or similar manufacturing processes, additional biocompatibility testing was deemed unnecessary for the M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System or M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System Instruments.

A comparison of the subject and predicate device is provided in the tables below.

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Technological comparison

Parameters	M.U.S.T. Sacral IliacScrew and PelvicTrauma System(Subject Device)	Synthes CannulatedScrews K962011 andK021932(Predicate Devices)	Asnis III CannulatedScrew SystemK000080 andK024060(Predicate Devices)
Screw Material	Titanium Alloy andStainless Steel	Titanium Alloy andStainless Steel	Titanium Alloy andStainless Steel
Washer Material	Titanium Alloy TypeII Anodized andStainless Steel	Titanium Alloy GoldAnodized andStainless Steel	Titanium Alloy andStainless Steel
WasherDiameter	Standard: Ø 13 mm, Ø15 mm, Ø 17 mm, Ø20 mmFavored Angle: Ø 15mm, Ø 17 mm, Ø 20mm	Ø 13 mm	Unknown
Screw Diameter	Ø 7.3 mm, Ø 8 mm, Ø9 mm and Ø 10 mm	Ø 6.5 mm and Ø 7.3mm	Ø 6.5 mm and Ø 8.0mm
Screw Length	70 mm to 200 mm	20 mm to 180 mm	30 mm to 180 mm
Screw Threaded	Partially and FullyThreaded	Partially and FullyThreaded	Partially and FullyThreaded
Screw ThreadDesign	Cannulated	Cannulated	Cannulated
Device Usage	Single Use	Single Use	Single Use
Biocompatibility	Implant withpermanent >30 day(Equivalencydetermined)	Implant withpermanent >30 day	Implant withpermanent >30 day
Sterilization	Gamma	Gamma	Non-sterile andGamma

M.U.S.T. Pelvic Trauma Screws and Washers

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Parameters	M.U.S.T. Sacral IliacScrew and PelvicTrauma System(Subject Device)	SI-LOK SacroiliacJoint FixationSystemK112028(Predicate Devices)	SImmetry SacroiliacJoint Fusion SystemK130092(Predicate Devices)
Material	Titanium Alloy	Titanium Alloy	Titanium Alloy
Coating	Hydroxyapatite(ASTM F1185)	w/Hydroxyapatite(ASTM F1185) orwithout	None
Diameter	8 mm, 9 mm, 10 mm	Unknown	6.5 mm to 12.5 mm
Length	25 mm to 80 mm	Unknown	30 mm to 70 mm
Threaded	Fully Threaded	Partially and FullyThreaded	Fully Threaded
Thread Design	Cannulated	Cannulated	Cannulated
Device Usage	Single Use	Single Use	Single Use
Biocompatibility	Implant withpermanent >30 day(Equivalencydetermined)	Implant withpermanent >30 day	Implant withpermanent >30 day
Sterilization	Gamma	Gamma	Gamma

M.U.S.T. Sacral Iliac Screws

Discussion

The technological differences between the subject and predicate devices do not raise new questions of safety and effectiveness. As seen above, the M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is the same or similar to the predicate devices in terms of intended use, materials of construction, design, threaded, thread design, coating, device usage, and sterility. Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System to the identified predicate devices.

VII. Performance Data

Based on the risk analysis, testing was conducted to written protocols with acceptance criteria that were based on standards. The following mechanical tests are being provided in support of a substantial equivalence determination:

Non-Clinical Studies

. Performance Tests
- o ASTM F543-13 Standard Specification and Test Methods for Metallic Medical Bone Screws
- o ASTM F2193-14 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

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Coating Tests ●
- ISO 13779-3: 2008 Implants for Surgery Hydroxyapatite Part 3: Chemical o Analysis and Characterization of Crystallinity and Phase Purity
- o ASTM F1185-03 (Reapproved 2014) Standard Specification for Composition of Hydroxyapatite for Surgical Implants
Pyrogenicity
- Medacta uses both the Bacterial Endotoxin Test (LAL test) according to European o Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>) and the Pyrogen Test according to USP chapter <151> for pyrogenicity determination.
- Medacta has no intentions of labeling the subject devices as non-pyrogenic or o pyrogen free.

Clinical Studies

No clinical studies were conducted. ●

VIII. Conclusion

The information provided above supports that the M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is as safe and effective as the predicate devices. Therefore, it is concluded that the M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.