K Number
K123164
Device Name
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
Date Cleared
2013-02-15

(129 days)

Product Code
Regulation Number
888.3070
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SpineFrontier® PedFuse® Pedicle Screw System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis). In addition, the SpineFrontier® PedFuse® Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine. When used in a percutaneous approach with MIS instrumentation, the SpineFrontier® PedFuse® Pedicle Screw System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (Pseudarthrosis) and severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.
Device Description
The SpineFrontier® PedFuse® Pedicle Screw System consists of longitudinal rods, polyaxial screws, tulips, transverse connectors, and instrumentation to facilitate installation of this system. The PedFuse® Pedicle Screw is offered in multiple screw types, with multiple diameters and lengths to accommodate individual patient needs. PedFuse® Pedicle Screw assemblies consist of the screw, a tulip, and a washer that secures the tulip to the screw and also serves as the saddle for the longitudinal rod. The tulip and screw designs allow the screw to have a polyaxial rotation relative to the tulip. A locking cap is placed on top of the pedicle screw assembly to secure the position of the implant and to retain the longitudinal rod. The PedFuse® Pedicle Screw assembly serves as the central fixation device to which various rods and cross connectors are secured to provide desired fixation. Longitudinal rods are provided in two configurations, straight and lordotic, have a fixed diameter (5.5mm), and vary by length. Cross connector assemblies are provided in multiple configurations, varying by length. Cross connectors are used to provide additional fixation support. For percutaneous, minimally invasive surgical (MIS) procedure, extended Respond tulips and bulleted rods are introduced. Instruments for the MIS technique are also used. The SpineFrontier® PedFuse® Pedicle Screw System components are fabricated from medical grade titanium conforming to ASTM F-136 specifications.
More Information

Not Found

No
The summary describes a mechanical spinal implant system and its components, with no mention of software, algorithms, or AI/ML capabilities.

Yes
The device is intended to provide "immobilization and stabilization of spinal segments" and is used as an "adjunct to fusion in the treatment of various acute instabilities or deformities." These actions are directly aimed at treating medical conditions, which aligns with the definition of a therapeutic device.

No

Explanation: The device is a pedicle screw system used for immobilization and stabilization of spinal segments as an adjunct to fusion. It is a treatment device, not a diagnostic one.

No

The device description clearly states that the system consists of physical components such as longitudinal rods, polyaxial screws, tulips, transverse connectors, and instrumentation. It also mentions the materials used (medical grade titanium). This indicates a hardware-based medical device, not a software-only one.

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

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Description and Intended Use: The SpineFrontier® PedFuse® Pedicle Screw System is a surgical implant designed to provide mechanical support and stabilization to the spine during fusion procedures. It is physically implanted into the patient's body.
  • Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, chemical reactions, or diagnostic testing. Its function is purely structural and mechanical.

Therefore, the SpineFrontier® PedFuse® Pedicle Screw System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The SpineFrontier® PedFuse® Pedicle Screw System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).

In addition, the SpineFrontier® PedFuse® Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.

When used in a percutaneous approach with MIS instrumentation, the SpineFrontier® PedFuse® Pedicle Screw System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (Pseudarthrosis) and severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.

Product codes

MNH, MNI

Device Description

The SpineFrontier® PedFuse® Pedicle Screw System consists of longitudinal rods, polyaxial screws, tulips, transverse connectors, and instrumentation to facilitate installation of this system.

The PedFuse® Pedicle Screw is offered in multiple screw types, with multiple diameters and lengths to accommodate individual patient needs. PedFuse® Pedicle Screw assemblies consist of the screw, a tulip, and a washer that secures the tulip to the screw and also serves as the saddle for the longitudinal rod. The tulip and screw designs allow the screw to have a polyaxial rotation relative to the tulip. A locking cap is placed on top of the pedicle screw assembly to secure the position of the implant and to retain the longitudinal rod.

The PedFuse® Pedicle Screw assembly serves as the central fixation device to which various rods and cross connectors are secured to provide desired fixation.

Longitudinal rods are provided in two configurations, straight and lordotic, have a fixed diameter (5.5mm), and vary by length.

Cross connector assemblies are provided in multiple configurations, varying by length. Cross connectors are used to provide additional fixation support.

For percutaneous, minimally invasive surgical (MIS) procedure, extended Respond tulips and bulleted rods are introduced. Instruments for the MIS technique are also used.

The SpineFrontier® PedFuse® Pedicle Screw System components are fabricated from medical grade titanium conforming to ASTM F-136 specifications.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thoracic, lumbar, and sacral spine, L5-S1 vertebra

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)

Mechanical testing includes performance assessments per the following recognized test methods: - ASTM Standard F1717, "Standard Test Methods for Spinal Implant -Constructs in a Vertebrectomy Model".

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K092420, K950099, K992739, K100605, K061591

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

5.0 510(k) Summary

1. Sponsor

FEB 1 5 2013

SpineFrontier, Inc. 500 Cummings Center Suite 3500 Beverly, MA 01915

Fredy H. Varela, MSRA, RAC Primary Contact: 1- 978-232-3990 Telephone:

Date Prepared:

December 14, 2012

2. Device Name and Classification:

SpineFrontier® PedFuse® Pedicle Screw Proprietary Names: System

Common/Usual Name: Pedicle Screw Spinal System

Classification Name:

Orthosis, Spondylolisthesis Spinal Fixation Orthosis, Spinal Pedicle Fixation (21 CFR 888.3070(b)(1)), Class II

Product Code:

MNH, MNI

3. Predicate Devices

K092420 - SpineFrontier® KRD1™ Pedicle Screw System K950099 - Synergy Posterior Spinal System K992739 - Synthes USS Click-X Variable Axis System K100605 – Spine Wave MIS Pedicle Screw System

K061591 – Medtronic CD Horizon Spinal System

4. Device Description

The SpineFrontier® PedFuse® Pedicle Screw System consists of longitudinal rods, polyaxial screws, tulips, transverse connectors, and instrumentation to facilitate installation of this system.

The PedFuse® Pedicle Screw is offered in multiple screw types, with multiple diameters and lengths to accommodate individual patient needs. PedFuse® Pedicle Screw assemblies consist of the screw, a

1

tulip, and a washer that secures the tulip to the screw and also serves as the saddle for the longitudinal rod. The tulip and screw designs allow the screw to have a polyaxial rotation relative to the tulip. A locking cap is placed on top of the pedicle screw assembly to secure the position of the implant and to retain the longitudinal rod.

The PedFuse® Pedicle Screw assembly serves as the central fixation device to which various rods and cross connectors are secured to provide desired fixation.

Longitudinal rods are provided in two configurations, straight and lordotic, have a fixed diameter (5.5mm), and vary by length.

Cross connector assemblies are provided in multiple configurations, varying by length. Cross connectors are used to provide additional fixation support.

For percutaneous, minimally invasive surgical (MIS) procedure, extended Respond tulips and bulleted rods are introduced. Instruments for the MIS technique are also used.

The SpineFrontier® PedFuse® Pedicle Screw System components are fabricated from medical grade titanium conforming to ASTM F-136 specifications.

5. Intended Use

The SpineFrontier® PedFuse® Pedicle Screw System is intended to provide immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).

In addition, the SpineFrontier® PedFuse® Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.

When used in a percutaneous approach with MIS instrumentation, the SpineFrontier® PedFuse® Pedicle Screw System is 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 instabilities or deformities of the thoracic, lumbar, and sacral

2

spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (Pseudarthrosis) and severe spondviolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.

6. Technological Characteristics and Substantial Equivalence Determination

The SpineFrontier® PedFuse® Pedicle Screw System was shown to be substantially equivalent to predicate devices through comparison of indications for use, function, operating principles and materials.

The SpineFrontier® PedFuse® Pedicle Screw System was evaluated in accordance with FDA Document, Guidance for Industry and FDA Staff – Spinal System 510(k)s, May 3, 2004, and has been found to meet criteria defined in the guidance document; and has been demonstrated to be substantially equivalent to predicate devices in terms of indications for use, function, materials and performance (mechanical testing). Clinical data was not required for this device.

Mechanical testing includes performance assessments per the following recognized test methods:

  • ASTM Standard F1717, "Standard Test Methods for Spinal Implant -Constructs in a Vertebrectomy Model".

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

February 15, 2013

SpineFrontier, Incorporated % Fredy H. Varela, MSRA, RAC Regulatory Affairs Specialist 500 Cummings Center, Suite 3500 Beverly, Massachusetts 01915

Re: K123164

Trade/Device Name: SpineFrontier® PedFuse® Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: December14, 2012 Received: December 18, 2012

Dear Mr. Varela:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

4

Page 2 -Fredy H. Varela, MSRA, RAC

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Erin - Meith

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

Enclosure

5

K123164 Page 1 of 1

4.0 Indications for Use Statement

510(k) Number (if Known): __ K123164

Device Name: SpineFrontier® PedFuse® Pedicle Screw System

Indications For Use:

The SpineFrontier® PedFuse® Pedicle Screw System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).

In addition, the SpineFrontier® PedFuse® Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.

When used in a percutaneous approach with MIS instrumentation, the SpineFrontier® PedFuse® Pedicle Screw System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (Pseudarthrosis) and severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.

Prescription Use: X (Part 21 CFR 801.109) Over-The-Counter Use:

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Colin O'Neill

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123164