(28 days)
No
The device description and performance studies focus on the mechanical properties, materials, and surgical application of bone screws and a pelvic trauma system. There is no mention of software, algorithms, image processing, or data analysis that would indicate the use of AI or ML.
Yes
This device is a therapeutic device because its intended use is for fracture fixation and sacroiliac joint fusion, which are treatments for medical conditions.
No
The device is described as a system for fracture fixation and joint fusion, which are therapeutic interventions, not diagnostic ones.
No
The device description clearly states it consists of various sized screws manufactured from Ti6A14V ELI and coated with rough Hydroxyapatite (HA), which are physical hardware components.
Based on the provided information, 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 directly on the patient's body for structural support and fusion.
- Device Description: The description details screws made of Ti6A14V ELI with a Hydroxyapatite coating, designed for implantation into bone. This is consistent with a surgical implant, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. This device is a physical implant used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The M.U.S.T. Sacral Illac 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 consists of various sized screws, manufactured from Ti6A14V ELI and coated with rough Hydroxyapatite (HA). The HA coating allows for biological fixation and potentially leads to arthrodesis.
The sacroiliac (SI) joint screws are hollow-body threaded fusion devices with a multiplefenestrated pattern shaft to promote arthrodesis, a self-tapping design to facilitate screw insertion, and a tapered tip to aid in guidance through pilot hole. Radial windowed slots along the shaft facilitate bone ingrowth after implantation and "bone filling" after insertion.
The SI joint screws are provided in standard and headless designs. The standard screw can be coupled to modular washers of different diameters to optimize and stabilize the contact between the screw head and the cortical bone and to improve the compression activity of the screw. The standard screws are provided sterile in three diameters (8, 9, and 10 mm) and multiple lengths (25 – 80 mm).
The headless screw has an anatomical shape which allows for full insertion into the bone. The headless screws are provided sterile in three diameters (7.5, 9, and 11 mm) and multiple lengths (30 - 75 mm). The M.U.S.T. Sacral Iliac Screws Extension introduces new sizes of these screws keeping the same diameters (7.5, 9, and 11 mm) with new lengths from 80 mm (5 mm increment).
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
Prescription Use
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)
The introduction of new sizes of M.U.S.T. SI-Joint Headless screws does not create a new worst case; therefore, the following performance testing from the predicate device was leveraged to support this submission:
- 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;
- 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;
- sterilization validation; and
- shelf-life testing
- Cadaver/Sawbones Workshop
A comparative analysis of the subject devices to the identified predicate and reference devices was performed to determine if this line-extension created a new worst-case product size. It was determined that the subject devices are substantially equivalent to the previously cleared predicate device and that the line-extension can be considered within the scope of the design verification and validation testing previously completed for the initial M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System product range.
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.
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
May 4, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Chris Lussier Senior Director, Quality and Regulatory Medacta International SA 3973 Delp Street Memphis, Tennessee 38118
Re: K203671
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
Dear Chris Lussier:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 13, 2021. Specifically, FDA is updating this SE Letter as an administrative correction for an incorrect Indications for Use Statement.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Colin O'Neill, M.B.E., OHT6: Office of Orthopedic Devices, (301) 796-6428, colin.oneill@fda.hhs.gov.
Sincerely.
Colin O'neill -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
January 13, 2021
Image /page/1/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 and Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration" with the word "Administration" on the second line.
Chris Lussier Senior Director, Quality and Regulatory Medacta International SA 3973 Delp Street Memphis, Tennessee 38118
Re: K203671
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: December 15, 2020 Received: December 16, 2020
Dear Mr. Lussier:
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
2
801 and Part 809; 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,
Colin O'neill -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
Device Name
M.U.S.T. Sacro-Iliac Screws and Pelvic Trauma System
Indications for Use (Describe)
The M.U.S.T. Sacral Illac 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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2.0 510(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, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director Quality / Regulatory, Medacta USA Date Prepared: December 15, 2020
II. 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 Codes: | HWC, HTN |
| Regulation Number: | 21 CFR 888.3040, 21 CFR 888.3030 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
Primary Predicate Device:
- . M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System, K193083, Medacta International SA
Reference Predicate Device
- M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System, K171595, Medacta ● International SA
5
IV. 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 consists of various sized screws, manufactured from Ti6A14V ELI and coated with rough Hydroxyapatite (HA). The HA coating allows for biological fixation and potentially leads to arthrodesis.
The sacroiliac (SI) joint screws are hollow-body threaded fusion devices with a multiplefenestrated pattern shaft to promote arthrodesis, a self-tapping design to facilitate screw insertion, and a tapered tip to aid in guidance through pilot hole. Radial windowed slots along the shaft facilitate bone ingrowth after implantation and "bone filling" after insertion.
The SI joint screws are provided in standard and headless designs. The standard screw can be coupled to modular washers of different diameters to optimize and stabilize the contact between the screw head and the cortical bone and to improve the compression activity of the screw. The standard screws are provided sterile in three diameters (8, 9, and 10 mm) and multiple lengths (25 – 80 mm).
The headless screw has an anatomical shape which allows for full insertion into the bone. The headless screws are provided sterile in three diameters (7.5, 9, and 11 mm) and multiple lengths (30 - 75 mm). The M.U.S.T. Sacral Iliac Screws Extension introduces new sizes of these screws keeping the same diameters (7.5, 9, and 11 mm) with new lengths from 80 mm (5 mm increment).
Indications for Use V.
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 sacroillitis.
VI. Comparison of Technological Characteristics
The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System SI joint screws and the predicate devices share the following characteristics:
- material of construction; ●
- diameters; ●
- coating and coating composition; ●
- biocompatibility; ●
6
- sterility;
- shelf life; and ●
- packaging. ●
The M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System SI joint screws are technologically different from the predicate device with respect to length of the screw and number of the radial windowed slots on the screw shaft.
These differences do not raise different questions of safety or effectiveness and design verification testing supports there are no new risks associated with the subject devices.
Performance Data VII.
The introduction of new sizes of M.U.S.T. SI-Joint Headless screws does not create a new worst case; therefore, the following performance testing from the predicate device was leveraged to support this submission:
- 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;
- 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;
- sterilization validation; and ●
- shelf-life testing ●
- Cadaver/Sawbones Workshop ●
A comparative analysis of the subject devices to the identified predicate and reference devices was performed to determine if this line-extension created a new worst-case product size. It was determined that the subject devices are substantially equivalent to the previously cleared predicate device and that the line-extension can be considered within the scope of the design verification and validation testing previously completed for the initial M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System product range.
VIII. Conclusion
The information provided within this submission supports that the M.U.S.T. SI-Joint Headless screws are are substantially equivalent to the predicate device.