K Number
K132788
Device Name
MYSPINE PEDICLE SCREW PLACEMENT GUIDES
Date Cleared
2014-05-23

(259 days)

Product Code
Regulation Number
888.3070
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MySpine is intended as a thoracic and lumbar posterior pedicle targeting quide for patients requiring spinal fusion between the levels of T1 to L5. MySpine Screw Placement Guides are intended to be used as anatomical perforating guides specific for a single patient anatomy to assist intraoperatively in the positioning of Pedicle screws in the vertebral body. MySpine is intended for use with M.U.S.T Pedicle Screw System and its cleared indications for use. Use of the quides involves surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surqiçal equipment components. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. MySpine Screw Placement Guides are intended for single use only.
Device Description
The MySpine Pedicle Screw Placement Guides are patient specific surgical instruments that allow for guided pedicle screw placement of the M.U.S.T pedicle screws (K121115). The M.U.S.T pedicle screws are guided through the patient's anatomically matched MySpine Pedicle Screw Placement Guides in order to provide optimal positioning according to the surgeon's preoperative planning. The MySpine software platform allows the surgeon to complete the preoperative planning in 3D based on the patient's spinal CT scans. The components of the MySpine Pedicle Screw Placement Guides include a Drill Guide (Polyamide PA 2200), Sleeves for Awls, Probes and Screw Drivers (Polyamide PA 2200). Sleeves for taps and drills (Wrought stainless steel AISI 630. ASTM F 899), and Vertebral Bone Models (Polyamide PA 2200). The MySpine Pedicle Screw Placement Guides are single use, external communicating devices with limited (<24 hours) contact duration and are provided in sterile and non-sterile versions.
More Information

No
The description focuses on patient-specific surgical guides based on pre-operative planning using CT scans and software, without mentioning AI/ML algorithms for planning or guide generation.

No.

The device is a surgical guide designed to assist in positioning pedicle screws during spinal fusion surgery, not to directly treat a condition or restore a function.

No

The device is described as a "thoracic and lumbar posterior pedicle targeting quide" and "Screw Placement Guides" used for "assisting intraoperatively in the positioning of Pedicle screws." It is a surgical tool that assists in physical placement during surgery, not for diagnosing a condition.

No

The device description explicitly states that the MySpine Pedicle Screw Placement Guides are patient-specific surgical instruments made of materials like Polyamide and Stainless Steel, which are hardware components. While there is associated software for planning, the device itself includes physical guides.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
  • MySpine's Function: MySpine is a surgical guidance system. It uses pre-operative imaging (CT scans) to create patient-specific guides that assist the surgeon in placing pedicle screws during spinal fusion surgery. It is a tool used during a surgical procedure, not a test performed on a biological sample outside the body.
  • Intended Use: The intended use clearly states it's a "thoracic and lumbar posterior pedicle targeting guide" and "anatomical perforating guides specific for a single patient anatomy to assist intraoperatively in the positioning of Pedicle screws." This describes a surgical aid, not a diagnostic test.
  • Device Description: The device description details physical components like drill guides, sleeves, and bone models, all designed for surgical use. It doesn't mention reagents, assays, or any components typically associated with in vitro testing.

In summary, MySpine is a surgical planning and guidance system, not a device used for testing biological samples to diagnose or monitor conditions.

N/A

Intended Use / Indications for Use

MySpine is intended as a thoracic and lumbar posterior pedicle targeting quide for patients requiring spinal fusion between the levels of T1 to L5.

MySpine Screw Placement Guides are intended to be used as anatomical perforating guides specific for a single patient anatomy to assist intraoperatively in the positioning of Pedicle screws in the vertebral body. MySpine is intended for use with M.U.S.T Pedicle Screw System and its cleared indications for use. Use of the quides involves surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of patient radiological images with identifiable placement anatomical landmarks and surqiçal equipment components. These components include patient-specific guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan.

MySpine Screw Placement Guides are intended for single use only.

Product codes

MNI

Device Description

The MySpine Pedicle Screw Placement Guides are patient specific surgical instruments that allow for guided pedicle screw placement of the M.U.S.T pedicle screws (K121115). The M.U.S.T pedicle screws are guided through the patient's anatomically matched MySpine Pedicle Screw Placement Guides in order to provide optimal positioning according to the surgeon's preoperative planning. The MySpine software platform allows the surgeon to complete the preoperative planning in 3D based on the patient's spinal CT scans.

The components of the MySpine Pedicle Screw Placement Guides include a Drill Guide (Polyamide PA 2200), Sleeves for Awls, Probes and Screw Drivers (Polyamide PA 2200). Sleeves for taps and drills (Wrought stainless steel AISI 630. ASTM F 899), and Vertebral Bone Models (Polyamide PA 2200). The MySpine Pedicle Screw Placement Guides are single use, external communicating devices with limited (

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

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MAY 2 3 2014 K132788 :: page 1 of 3

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510(k) Summary

Applicant/Sponsor: 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: Adam Gross Director of Regulatory, Quality and Compliance Medacta USA 1556 W Carroll Ave Chicago, IL 60607 Phone: (805) 910-6511 Fax: (805) 437-7553 Email: AGross@medacta.us.com

April 28, 2014 Date Prepared:

DEVICE INFORMATION

Trade/Proprietary Name: MySpine Pedicle Screw Placement Guides Common Name: Pedicle Screw Placement Guide Classification Name: orthosis, spinal pedicle fixation 21 CFR 888.3070 Class II Product Code: MNI

Predicate Device: K121115 M.U.S.T pedicle screw system, Medacta International

1

Product Description

The MySpine Pedicle Screw Placement Guides are patient specific surgical instruments that allow for guided pedicle screw placement of the M.U.S.T pedicle screws (K121115). The M.U.S.T pedicle screws are guided through the patient's anatomically matched MySpine Pedicle Screw Placement Guides in order to provide optimal positioning according to the surgeon's preoperative planning. The MySpine software platform allows the surgeon to complete the preoperative planning in 3D based on the patient's spinal CT scans.

The components of the MySpine Pedicle Screw Placement Guides include a Drill Guide (Polyamide PA 2200), Sleeves for Awls, Probes and Screw Drivers (Polyamide PA 2200). Sleeves for taps and drills (Wrought stainless steel AISI 630. ASTM F 899), and Vertebral Bone Models (Polyamide PA 2200). The MySpine Pedicle Screw Placement Guides are single use, external communicating devices with limited ( Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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