The SCI BacFix® Ti Spinal Fixation System consists of a combination of components which include rods, hooks, locking wedges, screws, transverse connectors, cable-screws, cables and spinous process grommets which are indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1).

When intended for pedicle screw fixation, implants are 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 or sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). Levels of pedicle screw attachment for these indications range to T1 to the sacrum.

As a pedicle screw system, the BacFix® Spinal Fixation System is also intended for patients having Grade 3 or Grade 4 spondylolisthesis at LS-S1, when utilizing autologous bone graft, when affixed to the posterior when deling and intended to be removed after solid fusion is established. Levels of pedicle screw fixation for this indication are from L3 to the sacrum.

When intended for non-pedicle, posterior screw fixation of the non-cervical spine, the indications are:

Idiopathic scoliosis.
Neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity.
Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.
Spinal fractures (acute reduction or late deformity).
Degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
Neoplastic disease.
Spondylolisthesis.
Spinal Stenosis.
Failed previous fusion.

The cable-screws, cables and spinous process grommets are indicated for:

Defect of pars lateralis.
Spondylolisthesis.

Cables and spinous processes grommets may be used for interspinous wiring if additional stability is needed.

Device Description

The Bach IT Spinal Fixation System is intended to or also with ASTM F136. The BacFix Spinal System is manufactured from thamall andy, which vehip.comectors and other ancillary components. The FTRaton System moudes secews, 1003, noored for market under K973687, and supplemented through II (calif Bach IX 11 Spillar Fixation System was cleared ink transverse connector), K003351 (addition of additional JTUK Submissions: Troughts (addition of end-to-end and side-by-side connectors).

AI/ML Overview

The provided document describes the BacFix Spinal Fixation System and its substantial equivalence to a predicate device, the Isola Spinal System, rather than presenting a study to prove acceptance criteria for a novel device through clinical trials or performance metrics against specific targets. This 510(k) submission relies on nonclinical (biomechanical) testing to demonstrate equivalence.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of traditional acceptance criteria with quantitative performance metrics, this submission uses the concept of "substantial equivalence" to a predicate device. The primary "acceptance criterion" is that the BacFix system's biomechanical properties fall within the established range of the predicate device.

Acceptance Criterion (via Substantial Equivalence to Isola Spinal System)	Reported Device Performance (BacFix Spinal Fixation System)
Indications for Use: Same as predicate device (Isola Spinal System).	Same as predicate, encompassing temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to S1), pedicle screw fixation for various conditions (T1 to sacrum), Grade 3 or 4 spondylolisthesis at L5-S1, and non-pedicle posterior screw fixation for non-cervical spine. Special indications for cable-screws, cables, and spinous process grommets.
Materials: Biocompatible, similar to predicate.	Titanium 6Al-4V. Predicate uses Stainless steel or titanium. (Deemed equivalent, as both are biocompatible and commonly used in spinal implants).
Components: Similar screws, rods, hooks, transverse connectors.	Screws, rods, hooks, transverse connectors. Predicate has "Same."
Product Labeling: Includes all necessary warnings.	Instructions for use and box labeling including all the necessary warning statements. Predicate has "Same."
Packaging/Sterilization: Non-sterile, single use only.	Non-sterile, single use only. Predicate has "Same."
Biomechanical Test Results: Stiffness range, per ASTM 1717-96, must be within the range of the Isola Spinal System.	Stiffness range, per ASTM 1717-96, within the range of the Isola Spinal System.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated in terms of number of devices or constructs. The document mentions "Mechanical testing was conducted on the stiffest and most flexible data collected for BacFix data." This implies a limited set of configurations or specimens were tested to represent the range of the device. The data provenance is not specified, but it would have been generated in a controlled laboratory setting (nonclinical).
Data Provenance: Nonclinical, laboratory-generated biomechanical test data designed to conform to ASTM F1717-96 (Standard Test Methods for Spinal Implant Constructs in a Corpectomy Model).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This is a nonclinical bench test, not a study involving expert assessment of medical images or patient outcomes. The "ground truth" here is the physical performance of the device under mechanical load, measured against established engineering standards (ASTM F1717-96) and compared to a predicate device's known performance.

4. Adjudication Method for the Test Set

Not applicable. This is a nonclinical bench test. No adjudication by human observers is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a 510(k) submission for a spinal fixation system, not an AI/imaging device. No MRMC study was performed or described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a mechanical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is the biomechanical performance data (stiffness range) of the BacFix system as measured according to ASTM F1717-96, and then compared to the known biomechanical performance data of the Isola Spinal System, also measured against the same standard. Essentially, direct physical measurement against a standardized test method.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device that does not use a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device submission.

Summary

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KO13887 1 of 2

FEB 1 2 2002

BacFix Spinal Fixation System Pedicle Screw Indications 510(k) Premarket Notification

SUBMITTED BY	Spinal Concepts, Inc.12012 Technology Blvd., Suite 100Austin, TX 78727
ESTABLISHMENTREGISTRATION NUMBER	1649384
CONTACT PERSON	David M. Hooper, Ph.D.Manager, Regulatory and Clinical AffairsPhone: 512-918-2700Fax: 512-918-2784
DATE PREPARED	November 21, 2001
CLASSIFICATION NAME	Pedicle Screw Spinal SystemSpinal Interlaminal Fixation Orthosis
COMMON NAME	Spinal Fixation System
PROPRIETARY NAME	BacFix Spinal Fixation System

DEVICE DESCRIPTION

DE VICE DESCRIP TION The Bach IT Spinal Fixation System is intended to or also with ASTM F136. The BacFix Spinal System is manufactured from thamall andy, which vehip.comectors and other ancillary components. The FTRaton System moudes secews, 1003, noored for market under K973687, and supplemented through II (calif Bach IX 11 Spillar Fixation System was cleared ink transverse connector), K003351 (addition of additional JTUK Submissions: Troughts (addition of end-to-end and side-by-side connectors).

INDICATIONS FOR USE

The SCI BacFix® Ti Spinal Fixation System consists of a combination of components which include rods, The SCI Dacrix IT Spulal Fradion System Connectors, cables and spinous process grommets.
hooks, locking wedges, screws, transverse connectors, cables and spinous process g hooks, locking wedges, screws, tability of the thoracic, the racolumbar, or lumbar spine (TI to S1).

When intended for pedicle screw fixation, implants are intended to provide immobilization of when intellection policity setew thation, inferent as an adjunct to fusion in the treatment of the discoses (download so chronic instabilities or deformities of the thoracic, lumbar or sacral spine: degenerative disc disel dice). Inconcernity discogenic back pain with degeneration of the disc confirmed by history and radiographic studies is lambosi spondylolisthesis with objective evidence of neurological impairment, fracture, discusses of the these spondylonsmosts with ogeetive enterious crudarthrosis). Levels of pedicle screw attachment for these indications range to T1 to the sacrum.

As a pedicle screw system, the BacFix® Spinal Fixation System is also intended for patients having Grade 3 or As a pondylolisthesis at LS-S1, when utilizing autologous bone graft, when affixed to the posterior Orade 4 spolidylonistics at 25 OT, when amazing and its established. Levels of pedicle screw fixation for this indication are from L3 to the sacrum.

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When intended for non-pedicle, posterior screw fixation of the non-cervical spine, the indications are:

. Idiopathic scoliosis.
Neuromuscular scollosis/kyphoscoliosis with associated paralysis or spasticity. .
Neuromuseular sconosisks phoseenments such as that resulting from laminectomy or . myelomeningocele.

2 cap 2

Spinal fractures (acute reduction or late deformity). .
Spillar fractures (double roads.orgin of discogenic origin with degeneration of the disc ● confirmed by history and radiographic studies).
Neoplastic disease. .
. Spondylolisthesis.
Spinal Stenosis. .
Failed previous fusion. .

The cable-screws, cables and spinous process grommets are indicated for:

Defect of pars lateralis. ●
Spondylolisthesis. .

Cables and spinous processes grommets may be used for interspinous wiring if additional stability is needed.

PREDICATE DEVICE

PREDICATE DE VICE I he Bacrix Spillal Fixation System is subsumany equivalent is as essent in the pedicle screw fixation.

DISCUSSION OF NONCLINICAL TESTS

DISCUSSION OF NONCEINVERD TEST S
Mechanical testing was conducted on the stiffest and most flexible data collected for Mechallical testing was conducted BacFix data were compared to available data ollected for ASTM 1717-90. The experimentally concected that the range of construct stiffiesses of the BacFix system is the 1sola Spinal System. 11 Tras assnof stiffnesses available with the Isola Spinal System.

COMPARISON TO THE PREDICATE DEVICE

COMPARISON TO THE TREDICATE DEFFICE
The BacFix Ti Spinal Fixation System is substantially equivalent to the Isola Spinal System (DePuy Acromed Inc., Cleveland, OH). Both systems are composed of screws, rods, hooks, transverse comectors Acromed inc., Cleveland, Orr. 'Dour Systems are voting Materials used in both systems are biocompatible and other ancinal y components to the BacFix system is contained within the possible range of and the railer of consuler surmisses of the been in by earling systems are substantially equivalent for all indications.

Device Name	BacFix Spinal Fixation System	Isola Spinal System
Indications for use	See above.	Same.
Materials	Titanium 6Al-4V	Stainless steel or titanium
Components	Screws, rods, hooks, transverseconnectors.	Same.
Product Labeling	Instructions for use and box labelingincluding all the necessary warningstatements.	Same.
Packaging/Sterilization	Non-sterile, single use only.	Same.
Biomechanical TestResults	Stiffness range, per ASTM 1717-96,within the range of the Isola SpinalSystem.	Stiffness range, per ASTM 1717-96, is wider than the BacFixSpinal Fixation System.

Table 1: TABLE OF SUBSTANTIAL EQUIVALENCE

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Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 2002

David M. Hooper, Ph.D. Manager, Regulatory and Clinical Affairs Spinal Concepts Incorporated 12012 Technology Boulevard - Suite 100 Austin, Texas 78727

Re: K013887

Trade Name: BacFix™ Ti Spinal Fixation System Trade Name: 21 CFR 888.3050 and 888.3050 and 888.3070 Regulation Number: 21 CFR 860.3050 and 600.5070
Regulation Name: Spondylolisthesis Spinal Fixation Device System, Pedicle Screw Spinal
Condidentifies Spondylolistics Spinal F System, and Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: MNH, MNI, KWP Dated: November 21, 2001 Received: November 23, 2001

Dear Dr. Hooper:

We have reviewed your Section 510(k) notification of intent to market the device referenced above We have reviewed your Section 310(K) notheaton of the indications for use stated in
and we have determined the device is substantially equivalent (Are 28, 1976, the enactment and we have determined the device is substantial.reprints to May 28, 1976, the enactment date the enclosure) to devices marketed in mich start contracted in accordance with the
of the Medical Device Amendments, or to accorded to the fore, market the of the Medical Device Amendinents, or to Govern in Act (Act). You may, therefore, market the provisions of the Pederal Food, Drug, and Cosmons of the Act. The general controls provisions of the device, subject to the general controls provisions of the rices, good manufacturing practice, Act melade requirentions against misbranding and adulteration.

If your device is classified (see above) into either class III (Special Controls) or class III (Premarket If your device is classified (set additional controls. Existing major regulations affecting your Approval), it may be subject to such additions. Title II, Parts 800 to 895. A substantially
device can be found in the Code of Federal Regulations. Title 21, Parts 800 to device can be found in the Code of Techante with the current Good Manufacturing Practices: General equirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General
requirement, as set forth in the Quality System Regulations the Food and Drug requirement, as set form in the Quanty Bystem rogencie (QS) inspections, the Food and Drug
regulation (21 CFR Part 820) and that, through periodic with the GMP regulation regulation (21 C.FK Part 820) and may and the entrely with the GMP regulation Administration (FDA) will verify suctifals) - caublish further announcements concerners concerning
may result in regulatory action. In addition, FDA may promorses notificati may result in regulatory action. In addition, I Dr. I may posse to your premarket notification your device in the Ederal Kegister. Trass note: the response sections 542 of the Act
submission does not affect any obligation you might have under sections of the Federal submission does not affect any obligation you might have around of other Federal laws or regulations.

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Page 2 - Dr. David Hooper

This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will allow you to begin narketing your device to a legally marketed notification. The FDA finding of substantial equivalence of your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at (301)
additionally 809.10 for in vitro diagnostic devices), please contact the Off additionally 809.10 for in vitro diagnosite the promotion and advertising of your device, please
594-4659. Additionally, for questions on the promotion and advertising of yo 594-4659. Additionally, for questions on the promotion and mease note the regulation entitled, the regulation entitled, and contact the Office of Compliance at (301) 594-407. Aller general information
"Misbranding by reference to premarket notification of Small Manufacturers "Misbranding by reference to premation (21 or the Division of Small Manufacturers
on your responsibilities under the Act may be obtained from the Division of Small Manufactur on your responsibilities under the Acc inay oc out in at 2011 at 12:00
Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address
1992 "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Muriam C. Provost

Col Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K013887
1α2

INIDICATIONS FOR USE STATEMENT

Page 1 of 2

K013887 510(k) Number (if known):

Device Name:

Spinal Concepts, Inc. BacFix Ti Spinal Fixation System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109) OR

Over-The-Counter: (Optional Format 1-2-96)

Muriam C. Provost

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K013857

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INIDICATIONS FOR USE STATEMENT

K013887

Page 2 of 2

When intended for non-pedicle, posterior screw fixation of the non-cervical spine, the indications are:

. Idiopathic scoliosis.
Neuromuscular scoliosis/kyphoscoliosis with associated . paralysis or spasticity.
Scoliosis with deficient posterior elements such as that . resulting from laminectomy or myelomeningocele.
Spinal fractures (acute reduction or late deformity). ●
Degenerative disc disease (back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies).
Neoplastic disease. ●
Spondylolisthesis. ●
Spinal Stenosis. ●
Failed previous fusion. .

The cable-screws, cables and spinous process grommets are indicated for:

Defect of pars lateralis. .
Spondylolisthesis. .

Cables and spinous processes grommets may be used for interspinous wiring if additional stability is needed.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use: (Per 21 CFR 801.109)

Over-The-Counter: (Optional Format 1-2-96)

Regulation Number and Section

§ 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.