K Number
K113361
Device Name
SECURIS SPINAL FIXATION
Manufacturer
Date Cleared
2012-04-03

(141 days)

Product Code
Regulation Number
888.3070
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Securis Spinal Fixation system is intended for immobilization and stabilization of the thoraco-lumbar-sacral spine (T1-S1) as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
Device Description
The subject Securis Spinal Fixation System consist of screws of various diameter and length, non-sterile, single use Cannulated Titanium (ASTM F136, Ti-6Al-4V) screws and set screws to be used in conjunction with 5.0 mm diameter Cobalt-Chrome-Molybdenum (CoCr, ASTM F1537) rods. The rods are provided in various lengths to form various configurations for the individual patients and surgical condition. Instruments and guide wires are made from various grades of stainless steel.
More Information

K070821, K 072866, K110099, K043522

No
The summary describes a mechanical spinal fixation system and does not mention any AI or ML components.

No
The device is a spinal fixation system, surgically implanted to immobilize and stabilize the spine, acting as an adjunct to fusion rather than a device that directly administers therapy.

No

This device is a spinal fixation system, intended for immobilization and stabilization of the spine as an adjunct to fusion, which is a treatment and not a diagnostic process.

No

The device description explicitly states it consists of physical components like screws, rods, instruments, and guide wires made of titanium, cobalt-chrome-molybdenum, and stainless steel. This indicates it is a hardware-based medical device, not software-only.

No, 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.
  • Device Description: The Securis Spinal Fixation system is a collection of implants (screws, rods) and instruments used within the body during surgery to stabilize the spine.
  • Intended Use: The intended use is for the immobilization and stabilization of the spine as an adjunct to fusion, which is a surgical procedure.

The information provided clearly describes a surgical implant system, not a diagnostic test performed on samples outside the body.

N/A

Intended Use / Indications for Use

"The Securis Spinal Fixation system is intended for immobilization and stabilization of the thoraco-lumbar-sacral spine (T1-S1) as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis). "

Product codes (comma separated list FDA assigned to the subject device)

NKB, MNI, MNH

Device Description

The subject Securis Spinal Fixation System consist of screws of various diameter and length, non-sterile, single use Cannulated Titanium (ASTM F136, Ti-6Al-4V) screws and set screws to be used in conjunction with 5.0 mm diameter Cobalt-Chrome-Molybdenum (CoCr, ASTM F1537) rods. The rods are provided in various lengths to form various configurations for the individual patients and surgical condition. Instruments and guide wires are made from various grades of stainless steel.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thoraco-lumbar-sacral spine (T1-S1)

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)

Bench testing was performed to support the equivalence of the proposed pedicle screw system in accordance with FDA Guidance "Guidance for Industry and FDA Staff: Spinal System 510(k) s." The following testing was performed in accordance with ASTM F1717: Static Compression Bending, Static Torsion, and Dynamic Compression Bending.

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.

K933881, K955348, K964024, K983583, K022623, K031585, K103287

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.

K070821, K 072866, K110099, K043522

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

§ 888.3070 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

K113361

APR - 3 2012

Section VII. 510(K) SUMMARY

Date Prepared

March 09, 2012

Name of Firm

Custom Spine, Incorporated 1140 Parsippany Blvd, Suite 201 Parsippany, NJ 07054 Phone: (973) 808-0019 Fax: (973) 808-0707

Official Correspondent

David Brumfield Senior VP of Research and Development, Quality, and Regulatory 1140 Parsippany Blvd. Suite 201 Parsippany, NJ 07054 Phone: (973) 265-5043 Fax: (973) 808-0707 E-mail: dbrumfield@customspine.com

Establishment Number 3005129649

Device Name

Legally Marketed Trade Name: Proposed Name SECURIS Spinal Fixation System Common Name: Pedicle Screw Spinal System Device Classification: Class III Regulation Number: 21 CFR 888.3070 Device Product Codes: NKB, MNI, MNH

Predicate Devices

Moss® Miami Spinal System (K933881, K955348, K964024, K983583, K022623), Optima® Spinal System (K031585), Synthes Pangea System (K103287), Custom Spine ISSYS LP (K070821, K 072866, K110099), ISSYS (043522).

Device Description

The subject Securis Spinal Fixation System consist of screws of various diameter and length, non-sterile, single use Cannulated Titanium (ASTM F136, Ti-6Al-4V)

Pg lot 2

1

screws and set screws to be used in conjunction with 5.0 mm diameter Cobalt-Chrome-Molybdenum (CoCr, ASTM F1537) rods. The rods are provided in various lengths to form various configurations for the individual patients and surgical condition. Instruments and guide wires are made from various grades of stainless steel.

Indications for Use

"The Securis Spinal Fixation system is intended for immobilization and stabilization of the thoraco-lumbar-sacral spine (T1-S1) as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis). "

Materials

The screws and setscrews are made from titanium (ASTM F-136, Ti-6Al-4V) and the rods are made from Cobalt-Chromium- Molybdenum (Co-28Cr-6Mo, ASTM F-1537).

Performance Data

Bench testing was performed to support the equivalence of the proposed pedicle screw system in accordance with FDA Guidance "Guidance for Industry and FDA Staff: Spinal System 510(k) s." The following testing was performed in accordance with ASTM F1717: Static Compression Bending, Static Torsion, and Dynamic Compression Bending.

Substantial Equivalence Statement

Documentation is provided which demonstrates that the Securis Spinal System is substantially equivalent to its predicate devices in terms of its material, design, and indications for use, and performance characteristics. Those comparisons are made in the substantial equivalence tables and the executive summary comparing the materials used in the systems, indications for use, and mechanical test data. The design characteristics of the SECURIS Spinal Fixation System is similar in technology (interconnections between the polyaxial head and bone screw) as the previously cleared ISSYS LP ((K070821, K 072866, K110099) and ISSYS (K043522) Polyaxial Screw Systems.

P 2.082

113361

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the words "Public Health Service" in a simple, sans-serif font. The text is black and appears to be printed on a white background. The words are arranged on a single line, with "Public" and "Health" capitalized, and "Service" also capitalized.

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

Custom Spine, Incorporated % Mr. David Brumfield Senior VP of Research and Development, Quality and Regulatory 1140 Parsippany Boulevard, Suite 201 Parsippany, New Jersey 07054

Re: K113361

Trade/Device Name: SECURIS Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: February 15, 2012 Received: February 15, 2012

APR - 3 2012

Dear Mr. Brumfield:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease) to 10g. 3 the enactment date of the Medical Device Amendments, or to conninered print to Milly 20, 1977, in ecordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmotion Actore, market the device, subject to the general controls provisions of the Act. The r ou may, merciols, manot alle a ct include requirements for annual registration, listing of general controls provision practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Trease noter ODFLEVE, 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 If your device is classified (boo acove). Existing major regulations affecting your device can be may be subject to additional controls. Existing of the 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 Frease be advised mar I Dri 3 losaante over device complies with other requirements of the Act
that FDA has made a determination that your device complies with other requirem that I DA has made a determinations administered by other Federal agencies. You must of any I'edelal statues and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Cr N Fall 607), aboning (21 OFR 803); good manufacturing practice requirements as set device-related adverse events) (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

Image /page/2/Picture/11 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other.

3

Page 2 - Mr. David Brumfield

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

K113361

Section VI. INDICATIONS FOR USE STATEMENT

KI13361 510(k) Number : ______________________________________________________________________________________________________________________________________________________________

The SECURIS Spinal Fixation System is intended for the immobilization and stabilization of the the SECONS Spine (T1-S1) as an adjunct to fusion in skeletally mature patients for the thorace fumber back are openerative disc disease (defined by discogenic back pain with following findicudentiful and a and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and previously failed fusion (pseudoarthrosis).

Prescription Use _ × (Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KIT3361 510(k) Number_