(63 days)
No
The device description focuses on the mechanical properties and design of the screws and system components, with no mention of AI or ML capabilities.
Yes.
This device is intended for fracture fixation and joint fusion, which are therapeutic interventions.
No
This device, the M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System, is described as an implantable system for fracture fixation and joint fusion, which are therapeutic interventions, not diagnostic procedures.
No
The device description clearly details physical hardware components (screws, washers) made of specific materials (titanium, stainless steel) and designed for surgical implantation. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fracture fixation of small and long bones of the pelvis, and for sacroiliac joint fusion." This describes a surgical implant used to physically stabilize and fuse bones within the body.
- Device Description: The description details the physical characteristics of screws and washers, materials used, and their design for surgical implantation.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does none of that.
The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is a surgical implant/device used for orthopedic procedures.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OUR, HWC, HTN
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 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-6Al-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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pelvis, Sacroiliac joint
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Studies
- Performance Tests
- ASTM F543-13 Standard Specification and Test Methods for Metallic Medical Bone Screws
- ASTM F2193-14 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
- Coating Tests
- ISO 13779-3: 2008 Implants for Surgery Hydroxyapatite Part 3: Chemical Analysis and Characterization of Crystallinity and Phase Purity
- 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 Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and the Pyrogen Test according to USP chapter for pyrogenicity determination.
- Medacta has no intentions of labeling the subject devices as non-pyrogenic or pyrogen free.
Clinical Studies
- No clinical studies were conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K021932, K962011, K000080, K024060, K112028, K130092
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.
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
1
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
2
Indications for Use
510(k) Number (if known)
Device Name
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
Indications for Use (Describe)
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.
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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3
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. ●
4
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
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.
VI. Comparison of Technological Characteristics
5
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.
6
Technological comparison
| Parameters | M.U.S.T. Sacral Iliac
Screw and Pelvic
Trauma System
(Subject Device) | Synthes Cannulated
Screws K962011 and
K021932
(Predicate Devices) | Asnis III Cannulated
Screw System
K000080 and
K024060
(Predicate Devices) |
|------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Screw Material | Titanium Alloy and
Stainless Steel | Titanium Alloy and
Stainless Steel | Titanium Alloy and
Stainless Steel |
| Washer Material | Titanium Alloy Type
II Anodized and
Stainless Steel | Titanium Alloy Gold
Anodized and
Stainless Steel | Titanium Alloy and
Stainless Steel |
| Washer
Diameter | Standard: Ø 13 mm, Ø
15 mm, Ø 17 mm, Ø
20 mm
Favored Angle: Ø 15
mm, Ø 17 mm, Ø 20
mm | Ø 13 mm | Unknown |
| Screw Diameter | Ø 7.3 mm, Ø 8 mm, Ø
9 mm and Ø 10 mm | Ø 6.5 mm and Ø 7.3
mm | Ø 6.5 mm and Ø 8.0
mm |
| Screw Length | 70 mm to 200 mm | 20 mm to 180 mm | 30 mm to 180 mm |
| Screw Threaded | Partially and Fully
Threaded | Partially and Fully
Threaded | Partially and Fully
Threaded |
| Screw Thread
Design | Cannulated | Cannulated | Cannulated |
| Device Usage | Single Use | Single Use | Single Use |
| Biocompatibility | Implant with
permanent >30 day
(Equivalency
determined) | Implant with
permanent >30 day | Implant with
permanent >30 day |
| Sterilization | Gamma | Gamma | Non-sterile and
Gamma |
M.U.S.T. Pelvic Trauma Screws and Washers
7
| Parameters | M.U.S.T. Sacral Iliac
Screw and Pelvic
Trauma System
(Subject Device) | SI-LOK Sacroiliac
Joint Fixation
System
K112028
(Predicate Devices) | SImmetry Sacroiliac
Joint Fusion System
K130092
(Predicate Devices) |
|------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Coating | Hydroxyapatite
(ASTM F1185) | w/Hydroxyapatite
(ASTM F1185) or
without | 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 Fully
Threaded | Fully Threaded |
| Thread Design | Cannulated | Cannulated | Cannulated |
| Device Usage | Single Use | Single Use | Single Use |
| Biocompatibility | Implant with
permanent >30 day
(Equivalency
determined) | Implant with
permanent >30 day | Implant with
permanent >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
8
- 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 ) and the Pyrogen Test according to USP chapter 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.