K Number

Device Name

Manufacturer

DANEK MEDICAL, INC.

Date Cleared

1999-01-06

(16 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral ioint: (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used as an anterolateral thoracic/lumbar system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

Device Description

The purpose of this 510(k) submission is to add the 3D Connector and associated screws to the TSRH® Spinal System.

The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, and connecting components. In addition, GDLH® rods, DYNA-LOK® bolts, CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® Plates, GDLH® rod/bolt connectors, GDLH® Variable Angle T-Bolts, and GDLH® and CD HORIZON™ set screws and locking screws may be used with the TSRH® Spinal System.

The TSRH® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D™ connectors and TSRH-3D™ screws are intended for posterior use only. All CROSSLINK® Plates are for posterior use and the CROSSLINK Axial and Offset Plates may be used anteriorly as well.

The TSRH Spinal System components are fabricated from either stainless steel conforming to ASTM F-138 or ISO 5832-1 or ISO 5832-9, or titanium alloy conforming to ASTM F-136 or ISO 5832-3. The TSRH Spinal System may sold sterile or non-sterile.

AI/ML Overview

This 510(k) summary (K984522) describes the addition of 3D Connectors and associated screws to the existing TSRH® Spinal System. The submission primarily focuses on establishing "substantial equivalence" to predicate devices rather than providing detailed acceptance criteria and performance study results in the manner common for AI/ML device submissions.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods is not available in this document. This is typical for a 510(k) submission for a physical medical device from this era, where the focus is on demonstrating that the new components are essentially the same as previously cleared components and do not raise new questions of safety or effectiveness.

Here's an attempt to answer the questions based on the provided text, while highlighting what is missing due to the nature of the document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (as stated in the document)
Identical Intended Use: To provide spinal fixation.	"The subject device is identical to the predicate device in intended use..."
Identical Indications For Use: (As listed in Section IV)	"The subject device is identical to the predicate device in... indications for use..."
Identical Levels of Attachment: (Not explicitly detailed, but implied by spinal system components)	"The subject device is identical to the predicate device in... levels of attachment..."
Identical Labeling: (Not explicitly detailed, but implied by regulatory compliance)	"The subject device is identical to the predicate device in... labeling..."
Identical Material: Stainless steel (ASTM F-138 or ISO 5832-1/5832-9) or Titanium alloy (ASTM F-136 or ISO 5832-3).	"The TSRH Spinal System components are fabricated from either stainless steel conforming to ASTM F-138 or ISO 5832-1 or ISO 5832-9, or titanium alloy conforming to ASTM F-136 or ISO 5832-3."
Identical Sterilization Method: Sterile or non-sterile options.	"The TSRH Spinal System may sold sterile or non-sterile."
Identical Method of Use: Implied to be similar to predicate devices for spinal fixation.	"The subject device is identical to the predicate device in... method of use..."
Identical Fundamental Scientific Technology: Implied to be mechanical spinal fixation.	"The subject device is identical to the predicate device in... fundamental scientific technology."
Substantial Equivalence to Predicate Devices: TSRH® Top Tightening T-Bolts and TSRH® Variable Angle Screws.	Concluded that "The TSRH®-3D Connector and associated screws are substantially equivalent to the TSRH® Top Tightening T-Bolts and TSRH® Variable Angle Screws."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not available/Applicable. This document does not describe a performance study with a test set of data points in the way an AI/ML device would. Instead, substantial equivalence is claimed based on similarities in design, materials, and intended use to existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not available/Applicable. No expert-derived ground truth for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not available/Applicable. No test set or adjudication method 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 available/Applicable. This is not an AI-assisted device, and no MRMC study is mentioned.

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

Not available/Applicable. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not available/Applicable. The concept of "ground truth" for a performance study is not relevant here as the submission focuses on substantial equivalence of physical components. The "truth" in this context is that the new components are comparable in design, material, and function to previously cleared devices.

8. The sample size for the training set

Not available/Applicable. No training set for an algorithm is discussed.

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

Not available/Applicable. No training set or ground truth establishment for it is discussed.

Summary

{0}------------------------------------------------

JAN 6 1999

TSRH® Spinal System 510(k) Summary- K984522 December 30, 1998

Sofamor Danek USA l. Company: 1800 Pyramid Place Memphis. TN 38132 (901) 396-3133

Proposed Proprietary Trade Name: TSRH® Spinal System ll.

III. Description

The purpose of this 510(k) submission is to add the 3D Connector and associated screws to the TSRH® Spinal System.

IV. Indications for Use:

{1}------------------------------------------------

and (4) who are having the device removed after the development of a solid fusion mass.

V. The TSRH®-3D Connector and associated screws are substantially equivalent to the TSRH® Top Tightening T-Bolts and TSRH® Variable Angle Screws. The subject device is identical to the predicate device in intended use, indications for use, levels of attachment, labeling, material, sterilization, method of use, and fundamental scientific technology.
©1998 Sofamor Danek

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is composed of three stylized human figures, represented by abstract lines, facing to the right. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1999 JAN

Mr. Richard W. Treharne, Ph.D. Vice President Research and Regulatory Affairs Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K984522

TSRH® Spinal System -- 3-D Connectors and Screws Regulatory Class: II Product Codes: MNI, KWP, KWQ, and MNH Dated: December 18, 1998 Received: December 21, 1998

Dear Dr. Treharne:

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.

{3}------------------------------------------------

Page 2 - Richard W. Treharne, Ph.D.

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,

cotter

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

{4}------------------------------------------------

December, 1998

K984522

510(k) Number (if known):

Device Name: TSRH® Spinal System

Indications for Use:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the TSRH® System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal turnor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below): and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used as an anterolateral thoracicllumbar system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

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

Concurrence of CDRH, Office of Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)	X
	OR
	Over-The-Counter Use_
	(Optional 1-2-96)
(Division Sign-Off)Division of General Restorative Devices
510(k) Number	1298452

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.