The Spinal Concepts, Inc. BacFix™ 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 (T)-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 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 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 BacFix™ Spinal Fixation System consists of longitudinal members (spinal rods), in a variety of diameters (1/4" and 3/16") and lengths; spinal anchor components, hooks and screws, of various sizes (6.0-7.5mm diameter screws) and types; locking connectors (wedge and nut) 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 and are secured with a three point shear clamp (wedge and nut). The open face of the wedge may be snapped over the spinal rod. Thus the component and wedge may be preassembled outside the wound, eliminating the need to attach the nut within the surgical opening and the need to pre-plan the position of each eyebolt on the spinal rod. Furthermore, an anchor component may be added to (or removed from) the construct at any time during the procedure.

AI/ML Overview

The provided document describes the BacFix™ Spinal Fixation System (K983258), a medical device. The "study" that proves the device meets acceptance criteria is a mechanical testing comparison study rather than a clinical trial involving human subjects. This is a common approach for Class II medical devices seeking 510(k) clearance, where substantial equivalence to a legally marketed predicate device is the primary pathway.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Withstand clinical loading	"demonstrated the BacFix™ to be substantially equivalent to the Zimmer Modulock Posterior Spinal System and the Sofamor Danek TSRH Spinal System and able to withstand clinical loading"
Maintain mechanical integrity	"demonstrated the BacFix™ to be substantially equivalent to the Zimmer Modulock Posterior Spinal System and the Sofamor Danek TSRH Spinal System and able to ... maintain mechanical integrity."
Substantial equivalence to predicate devices (Zimmer Modulock, Sofamor Danek TSRH) in material, design, and function	The entire "Substantial Equivalence" section (III) details the claimed equivalence in materials (316L Stainless Steel & 22-13-5 Stainless Steel), design (longitudinal members, hooks, screws, locking connectors, transverse connector assembly), and function (indications for use, as confirmed by mechanical testing).

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

Sample Size: The document does not specify the exact number of test samples (e.e. rods, screws, hooks) used for the static and fatigue mechanical testing.
Data Provenance: Not explicitly stated, but the testing would have been conducted in a laboratory setting, likely in the US, as the company is based in Austin, Texas. It is a prospective test in the sense that the device was manufactured specifically for these tests. It is not related to patient data.

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

This question is not applicable in the traditional sense for this type of mechanical testing. The "ground truth" for mechanical testing is established by engineering standards and comparative data with predicate devices, not by expert consensus on clinical cases. The comparison was to published data of predicate devices.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing data is evaluated against pre-defined engineering standards and comparative data, not through an adjudication process by human experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC study was not done. This is a mechanical device, and its approval is based on substantial equivalence to predicate devices through material and mechanical performance, not through a comparative effectiveness study involving human readers or clinical outcomes in the way AI/radiology devices might.

6. Standalone Performance Study

Yes, a standalone study was done, but it's mechanical. The "Mechanical Testing" section (VII) describes static and fatigue testing performed solely on the BacFix™ System. The results of this standalone testing were then compared to published data of "various other hook, rod and screw spinal fixation systems." This is a standalone performance of the device's mechanical properties, not a standalone algorithm performance.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on:
- Engineering Standards: Implied standards for static and fatigue strength for spinal fixation systems.
- Predicate Device Performance Data: Published mechanical testing data from the Zimmer Modulock Posterior Spinal System and the Sofamor Danek TSRH Spinal System.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable. As above, there is no "training set" for a physical medical device.

Summary

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1983258

OCT 21 1998

SUMMARY OF SAFETY AND EFFECTIVENESS BacFix™ Spinal Fixation System (K983258)

General Information I.

Classification Name:	87 Orthopedics
Common Name:	Appliance, Fixation, Spinal Interlaminal
Device Trade Name:	BacFix™ 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: Teena M. Augostino Director, Clinical and Regulatory Affairs

Summary Preparation Date: October 15, 1998

II. Predicate Device

The Spinal Concepts, Inc. BacFix™ Spinal Fixation System claimed to be substantially equivalent in material, design, and function to the Zimmer Modulock Posterior Spinal System and the Sofamor Danek TSRH Spinal System

III. Device Description

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IV. Sterilization

The BacFix™ 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 sterilization parameters described in the package insert in order to achieve a sterility assurance level of 10-6

V. Indications for Use

When intended for pedicte 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 non-cervical spine, the indications are:

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

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Substantial Equivalence VI.

316L StainlessSteel & 22-13-5Stainless Steel	Rods (hard and soft - various sizes and lengths)Hooks (laminar, pedicle, lumbar - right and left),Rod links/wedges (various sizes and lengths)Screws (angled, straight, various sizes and diameters)	Bilateral, dual spinal rods connected with transverse rod linkages.Spinal rods are attached to thoracic & lumbar spine with hooks & to sacral spine with screws	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 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 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"1. Idiopathic scoliosis, 2. Neuromuscular scoliosis/ kyphoscoliosis with associated paralysis or spasticity, 3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, 4. Spinal fractures (acute reduction or late deformity), 5. Degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), 6. Neoplastic disease, 7. Spondylolisthesis, 8. Spinal stenosis and 9. Failed previous fusion.
316L StainlessSteel & 22-13-5Stainless Steel	Rods, hooks (laminar, pedicle, lumbar), cross-links rods, screws (angled & straight)	Bilateral dual spinal rods connected with transverse rod couplers.Spinal rods are attached to thoracic and lumbar spine	To provide temporary stabilization of (T1 to S1) as an adjunct to spinal bone grafting procedures. The system is also used for the correction and stabilization of scoliotic curves, for the prevention of recurrence of undesired scoliotic curves and for the stabilization of weakened trunks. When labeled for pedicle screw fixation, the implants are intended for use in grade 3 and 4 spondylolisthesis at L5-S1
		with hooks andsacral spinewith screws.	utilizing autogenous bone graft and intended tobe removed after solid fusion is attained.Levels of attachment for this indication rangefrom L3 to the sacrum. When labeled for non-pedicle screw fixation, the system is intendedfor hook, wire and/or sacral/iliac screw fixationfrom the thoracic spine to the ileum/sacrum.
316L StainlessSteel	Rods, hooks(laminar, bifidpedicle andlumbar), rodcoupler, screws(angled andstraight)	Bilateral, dualspinal rodsconnected withtransverse rodlinkages.Spinal rods areattached tothoracic &lumbar spinewith hooks &to sacral spinewith screws	To provide temporary stabilization of (T1 toS1) as an adjunct to spinal bone graftingprocedures. The system is also used for thecorrection and stabilization of scoliotic curves,for the prevention of recurrence of undesiredscoliotic curves and for the stabilization ofweakened trunks. When labeled for pediclescrew fixation, the implants are intended foruse in grade 3 and 4 spondylosisthesis at L5-S1,utilizing autogenous bone graft and intended tobe removed after solid fusion is attained.Levels of attachment for this indication rangefrom L3 to the sacrum. When labeled for non-pedicle screw fixation, the system is intendedfor hook, wire and/or sacral/iliac screw fixationfrom the thoracic spine to the ileum/sacrum.

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VII. Mechanical Testing

Static and fatigue testing was performed on the BacFix™ System. These data were compared with published data of various other hook, rod and serew spinal fixation systems. The results of this testing demonstrated the BacFix™ to be substantially equivalent to the Zimmer Modulock Posterior Spinal System and the Sofamor Danek TSRH Spinal System and able to withstand clinical loading and maintain mechanical integrity.

VIII. Conclusion

The BacFix™ Spinal Fixation System is considered to be substantially equivalent in design, material and function to the Zimmer Modulock Posterior Spinal System and the Sofamor Danek TSRH Spinal System.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding it.

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

Re: K983258

BacFix™ stainless steel 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 vour 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
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and

Radiological Health

Enclosure

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	INDICATION FOR USE STATEMENT
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Page I of I

510(k) Number (if known): K983258

JI ZUJ - 4 JUL

1 ねぇ 1 コメリカ - שער 1 ווכן 1 מא

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

The Spinal Concepts, Inc. BacFix™ Spinal Fixation System consists of a Indications for Use: 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 (T)-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:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use:	X(Per 21 CFR 801.109)
	Over-The-Counter(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K983258

Regulation Number and Section

N/A