The Spinal Concepts, Inc. BacFix™ ti Spinal Fixation System consists of a combination of components which include rods, hooks, locking wedges, screws and transverse connectors which are indicated to provide temporary stability of the thoracic, thoracolumbar or lumbar spine (T1-SI).

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 and sacral spine: Degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). Levels of pedicle screw attachment for these indications range from T1 to the sacrum.

In addition, when intended for pedicle screw fixation, implants are intended for treatment of severe spondylolisihesis (grades 3 and 4) of the vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of implants after the attainment of solid fusion. The levels of screw fixation for these indications range from L3 to the sacrum.

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

Idiopathic scoliosis.
Neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spacticity.
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.

Device Description

The Spinal Concepts, Inc. BacFix™ ti Spinal Fixation System consists of a combination of titanium components which include rods, hooks, locking wedges, screws and transverse connectors which are indicated to provide temporary stability of the thoracic, thoracolumbar or lumbar spine (TI-S1). The BacFix™ Spinal Fixation System consists of longitudinal members (spinal rods), in diameters of 5.5 and 6.0mm, in two hardnesses, and a variety of lengths; spinal anchor components, hooks and screws (mono-axial and multi-axial) of various diameters (5.0, 6.0, 7.0 and 8.0mm) and lengths; locking connectors (threaded wedge and nut or non-threaded wedge and locking clip) sized to fit the spinal rods; and a transverse connector assembly (link), also in various lengths. Hooks and screws may be placed at any position along the spinal rods. Wedges are used to connect the spinal rods to screws (hooks and links). These components are preassembled outside the wound, eliminating the need to pre-plan the position of each eyebolt on the spinal rod. A spinal rod is positioned within the open face of the wedge. Fixation of the construct is accomplished using an instrument that applies a three point shear clamp. Addition of the hex nut (when using threaded wedge) and optional use of the locking clip (when using the non-threaded wedge) complete the implant. Anchor components may be added to (or removed from) the construct at any time during the procedure.

AI/ML Overview

The provided document describes the BacFix™ ti Spinal Fixation System (K983260). This is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials. Therefore, the questions related to AI/algorithm performance, ground truth, expert adjudication, training/test sets, and human reader improvement are not applicable to this type of document.

The document focuses on demonstrating substantial equivalence through:

Material, design, and function comparison to predicate devices.
Mechanical testing to show the device can withstand clinical loading and maintain mechanical integrity.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" for a 510(k) submission are that the new device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness. This is demonstrated through comparison of materials, design, function, and performance data where relevant.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance
Material Equivalence: Materials used for the implant.	BacFix™ ti System: - Ti-6Al-4V ELI (ASTM F-136) - Ti-6AL-7Nb (ASTM F-1295) - Unalloyed titanium (ASTM F-67)Predicate BacFix™ System: - 316L Stainless Steel - 22-13-5 Stainless SteelSynthes Universal Spinal System (Predicate): - Ti-6AL-7NB - CP (chemically Pure) titanium
Design Equivalence: Components and overall structure.	BacFix™ ti System: Rods, hooks, locking wedges, screws, transverse connectors. Bilateral, dual spinal rods connected with transverse rod linkages. Rods attached to thoracic/lumbar spine with hooks, and sacral spine with screws. Reported Performance: "Substantially equivalent in material, design, and function to the existing BacFix™ Spinal Fixation System and the Synthes Universal Spinal System."
Function Equivalence: Purpose and mechanism of action.	BacFix™ ti System: Provides temporary stability of the thoracic, thoracolumbar or lumbar spine (T1-S1) as an adjunct to fusion for various instabilities/deformities (e.g., spondylolisthesis, fracture, scoliosis, kyphosis, spinal tumor, failed fusion). Also for severe spondylolisthesis (grades 3&4) and non-pedicle posterior screw fixation for various conditions. Reported Performance: "Substantially equivalent in material, design, and function to the existing BacFix™ Spinal Fixation System and the Synthes Universal Spinal System."
Mechanical Performance: Ability to withstand loads.	Static and Fatigue Testing Results: "demonstrated the BacFix™ ti to be substantially equivalent to the BacFix™ and the Synthes Universal Spine System and able to withstand clinical loading and maintain mechanical integrity."

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. The "test set" in this context refers to the samples of the device and predicate devices used for mechanical testing. The specific number of devices tested is not provided in this summary.
Data Provenance: Not specified, but likely laboratory testing conducted by the manufacturer or a contracted lab. The document does not indicate country of origin for mechanical testing data. The study is a pre-market submission, not a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study involving expert assessment of data to establish ground truth (e.g., image interpretation). The "truth" here is established by engineering and mechanical testing standards.

4. Adjudication method for the test set

Not applicable. No expert adjudication process is described for mechanical testing.

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 spinal fixation system, not an AI diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a spinal fixation system, not an AI diagnostic device.

7. The type of ground truth used

Ground Truth: For the mechanical testing, the "ground truth" or reference performance is established by the performance of the legally marketed predicate devices (BacFix™ Spinal Fixation System and Synthes Universal Spinal System) and published data, adhering to accepted engineering and biomechanical standards for spinal implants. This is based on objective physical measurements rather than expert consensus on medical images or pathology.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" as this is not an AI/machine learning device.

Summary

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OCT 2 1 1998

KG83260

SUMMARY OF SAFETY AND EFFECTIVENESS BacFix™ ti Spinal Fixation System (K983260)

I. General Information

Classification Name:	87 Orthopedics
Common Name:	Appliance, Fixation, Spinal Interlaminal
Device Trade Name:	BacFix™ ti Spinal Fixation System
Classification Code:	This device has been placed in Class II by theOrthopedics Panel.
Submitter's Name & Address:	Spinal Concepts, Inc.8200 Cameron Road, Suite B-160Austin, Texas 78754 U.S.A.(512) 339-4800
Establishment Registration No:	1649384
Contact Person:	Tema M. Augostino

Director, Clinical and Regulatory Affairs

October 15, 1998 Summary Preparation Date:

II. Predicate Device

The Spinal Concepts, Inc. BacFix™ ti Spinal Fixation System claimed to be substantially equivalent in material, design, and function to the existing BacFix™ Spinal Fixation System and the Synthes Universal Spinal System.

III. Device Description

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locking clip (when using the non-threaded wedge) complete the implant. Anchor components may be added to (or removed from) the construct at any time during the procedure.

IV. Sterilization

The BacFix™ ti Spinal Fixation System implants and instrumentation may be provided sterile or non-sterile. Both implants and instruments must be sterilized prior to use in accordance with the recommended storilization parameters described in the package insert in order to achieve a sterility assurance level of 10-6.

V. Indications for Use

In addition, when intended for pedicle screw fixation, implants are intended for treatment of severe spondylolisthesis (grades 3 and 4) of the vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of implants after the attainment of solid fusion. The levels of screw fixation for these indications range from L3 to the sacrum.

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

Idiopathic scoliosis. ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
in Neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spacticity.
Scoliosis with deficient posterior elements such as that resulting from laminectomy 3. or myelomeningocele.
Spinal fractures (acute reduction or late deformity). ব
Degenerative disc disease (back pain of discogenic origin with degeneration of the રું. disc confirmed by history and radiographic studies).
1. Neoplastic disease.
1. Spondylolisthesis.
1. Spinal stenosis.
1. Failed previous fusion.

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Substantial Equivalence VT.

Ti-6Al-4V ELI(ASTM F-136)or Ti-6AL-7Nb(ASTM F-1295)& unalloyedtitanuium(ASTM F-67)	Rods (hard and soft- various lengths)Hooks (laminar,pedicle, lumbar -right and left),Rod links/wedges(various sizes andlengths)Screws (angled,straight, varioussizes anddiameters)	Bilateral, dualspinal rodsconnected withtransverse rodlinkages.Spinal rods areattached tothoracic &lumbar spinewith hooks &to sacral spinewith screws	When intended for pedicle screwfixation, implants are intended toprovide immobilization andstabilization of spinal segments inskeletally mature patients as anadjunct to fusion in the treatment ofthe following acute and chronicinstabilities or deformities of thethoracic, lumbar and sacral spine:Degenerative spondylolisthesis withobjective evidence of neurologicimpairment, fracture, dislocation,scoliosis, kyphosis, spinal tumor andfailed previous fusion(pseudarthrosis). Levels of pediclescrew attachment for these indicationsrange from T1 to the sacrum.In addition, when intended for pediclescrew fixation, implants are intendedfor treatment of severespondylolisthesis (grades 3 and 4) ofthe vertebra in skeletally maturepatients receiving fusion byautogenous bone graft having implantsattached to the lumbar and sacral spinewith removal of implants afterattainment of solid fusion. The levelsof screw fixation for these indicationsrange from L3 to the sacrum.When intended for non-pedicle,posterior screw fixation of the non-cervical spine, the indications are"1. Idiopathic scoliosis, 2.Neuromuscular scoliosis/kyphoscoliosis with associatedparalysis or spacticity, 3. Scoliosiswith deficient posterior elements suchas that resulting from laminectomy ormyelomeningocele, 4. Spinal fractures(acute reduction or late deformity), 5.Degenerative disc disease (back painof discogenic origin with degenerationof the disc confirmed by history andradiographic studies), 6. Neoplasticdisease, 7. Spondylolisthesis, 8. Spinalstenosis and 9. Failed previous fusion.
316L StainlessSteel & 22-13-5Stainless Steel	Rods (hard and soft- various sizes andlengths)Hooks (laminar,pedicle, lumbar -right and left),Rod links/wedges(various sizes andlengths)Screws (angled.straight, varioussizes anddiameters)	Bilateral, dualspinal rodsconnected withtransverse rodlinkages.Spinal rods areattached tothoracic &lumbar spinewith hooks &to sacral spinewith screws	Same as above
Ti-6AL-7NB &CP (chemicallyPure) titanium	Rods (hard andsoft-various sizesand lengths),Hooks (laminar,pedicle, lumbar.transverse process),rod collar,transverse bars,Screws (varioussizes anddiameters)	Bilateral, dualspinal rodsconnected withtransverse rodlinkages.Spinal rods areattached tothoracic &lumbar spinewith hooks &to sacral spinewith screws	Intended for correction of anterolaterallordotic deformities of the spine,scoliosis, pseudarthrosis and fractureor dislocation of the thoracolumbarspine (T8-L5).

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VII. Mechanical Testing

Static and fatigue testing was performed on the BacFix™ ti and the existing, BacFix™ Systems. These data were compared with published data of various other hook, rod and screw spinal fixation systems. The results of this testing demonstrated the BacFix™ ti to be substantially equivalent to the BacFix™ and the Synthes Universal Spine System and able to withstand clinical loading and maintain mechanical integrity.

VIII. Conclusion

The BacFix™ ti Spinal Fixation System is considered to be substantially equivalent in design, material and function to the existing BacFix™ System and the Synthes Universal Spine System.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1998

Ms. Teena M. Augostino Director, Regulatory and Clinical Affairs Spinal Concepts, Inc. 8200 Cameron Road, B-160 Austin, Texas 78754

K983260 Re:

BacFix™ ti Spinal Fixation System - expanded uses Regulatory Class: II Product Codes: MNI, KWP, and MNH Dated: September 11, 1998 Received: September 16, 1998

Dear Ms. Augostino:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Teena M. Augostino

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

K983260 510(k) Number (if known):

Spinal Concepts, Inc. BacFix™ ti Spinal Fixation System Device Name:

The Spinal Concepts, Inc. BacFix™ ti Spinal Fixation System consists of Indications for Use: a combination of components which include rods, hooks, locking wedges, screws and transverse connectors which are indicated to provide temporary stability of the thoracic, thoracolumbar or lumbar spine (T1-SI).

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 and sacral spine: Degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). Levels of pedicle screw attachment for these indications range from T1 to the sacrum.

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

Idiopathic scoliosis. 】.
associated Neuromuscular scoliosis/kyphoscoliosis with 2. paralysis or spacticity.
Scoliosis with deficient posterior elements such as that resulting 3. from laminectomy or myelomeningocele.
Spinal fractures (acute reduction or late deformity). ব .
Degenerative disc disease (back pain of discogenic origin with ર : degeneration of the disc confirmed by history and radiographic studies).
Neoplastic disease. ఈ
Spondylolisthesis. 7.
Spinal stenosis. 8.
Failed previous fusion. 9.

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

Prescription Use:	X
(Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices

510(k) Number	1 K 983260
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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.