The intended use of the Malibu Spinal System is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

The intended use of the Malibu Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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. The indications for use are as follows:

degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
spondylolisthesis,
trauma (i.e., fracture or dislocation),
spinal stenosis.
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
spinal tumor,
pseudoarthrosis, and/or
failed previous fusion.

The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:

degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
spondylolisthesis
trauma (i.e., fracture or dislocation),
spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
tumor,
pseudarthosis, and/or
failed previous fusion.

Device Description

The Malibu Spinal System includes titanium alloy iliac monaxial and monaxial screws. Both screw types will be offered in numerous diameters and lengths. The screw is comprised of an integrated body and housing. Both screws are designed to be part of the Malibu system, but are compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The Malibu Spinal System will also include titanium alloy caps, rods, and hooks. The caps will come in one size, the rods in two diameters, and the four types of hooks in a variety of sizes. All of these devices are designed to be a part of the stand alone Malibu Spinal System, but are compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The Malibu Spinal System will offer a wide variety of instruments that range from rod forks to hook pushers. These various instruments will be made primarily from various grades of stainless steel with a few components made from titanium alloy, Radel, and medical grade Pomalux. These items are supplied "NON-STERILE" and must be sterilized prior to use.

AI/ML Overview

The acceptance criteria and study proving device performance are described below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Feature	Acceptance Criteria (Implied)	Reported Device Performance
Intended Use	Substantially equivalent to predicate devices for temporary/permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization for spinal fusions.	"The intended use of the Malibu Spinal System... is substantially equivalent to the intended use of the predicate devices." (Page 3)
Indications for Use	Substantially equivalent to predicate devices for conditions like DDD, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudoarthrosis, and failed previous fusion (with specific details for Pedicle Screw Systems/Spondylolisthesis systems and Interlaminal Fixation Orthoses/Hook Systems).	"The overall designs... are substantially equivalent to the predicate devices. See Table 1..." (Page 3)
Design	Substantially equivalent for iliac monoaxial screws, monoaxial screws, fixed locking caps, rods, hooks, and components.	"Similar" to predicate devices for each component listed. (Table 1, Page 3)
Iliac Monoaxial Screws	Substantially equivalent in design.	"See prints" (implies detailed design specifications match predetermined criteria or predicate designs). "Similar" to predicate. (Table 1, Page 3)
Monoaxial Screws	Substantially equivalent in design.	"See prints" (implies detailed design specifications match predetermined criteria or predicate designs). "Similar" to predicate. (Table 1, Page 3)
Caps	Substantially equivalent in design.	"See prints" (implies detailed design specifications match predetermined criteria or predicate designs). "Similar" to predicate. (Table 1, Page 3)
Laminar Hooks	Substantially equivalent in design.	"See prints" (implies detailed design specifications match predetermined criteria or predicate designs). "Similar" to predicate. (Table 1, Page 3)
Pedicle Hooks	Substantially equivalent in design.	"See prints" (implies detailed design specifications match predetermined criteria or predicate designs). "Similar" to predicate. (Table 1, Page 3)
Offset Hooks	Substantially equivalent in design.	"See prints" (implies detailed design specifications match predetermined criteria or predicate designs). "Similar" to predicate. (Table 1, Page 3)
Material	Titanium alloy, similar to predicate devices.	"Titanium alloy" for Malibu Spinal System, "Similar" to predicate. (Table 1, Page 3)
Sterile	Non-sterile, similar to predicate devices.	"Non-sterile" for Malibu Spinal System, "Similar" to predicate. (Table 1, Page 3)
Method of Sterilization	High-temperature steam, similar to predicate devices.	"High-temperature steam" for Malibu Spinal System, "Similar" to predicate. (Table 1, Page 3)
Mechanical Strength	Demonstrated to be similar to predicate devices based on test results.	"See test results" for Malibu Spinal System, "Similar" to predicate. (Table 1, Page 3)

Study Details:

The provided document is a 510(k) summary for a medical device (Malibu Spinal System). It focuses on demonstrating substantial equivalence to predicate devices rather than conducting a de novo study to establish new performance criteria. Therefore, most of the requested information regarding "study" parameters (like sample size, experts for ground truth, adjudication, MRMC, standalone performance, training set) is not directly applicable or explicitly stated in this type of regulatory submission. The "study" here is a comparison analysis to predicate devices.

2. Sample Sizes and Data Provenance:

Test Set Sample Size: Not explicitly stated. The comparison is made against existing predicate devices, implying that their established performance and characteristics serve as the "test set" for equivalence.
Data Provenance: Not explicitly stated. The comparison is to predicate devices (Synthes Click'X Monoaxial Screw System, DePuy Acromed's Moss Miami System, and SeaSpine Inc.'s UCR Spinal System), which are legally marketed devices. The data for these predicate devices would have been generated during their own regulatory submissions or clinical use. The Malibu Spinal System itself underwent "Mechanical Strength" testing, the details of which are not provided (e.g., number of units tested, conditions, etc.).

3. Number of Experts and Qualifications for Ground Truth:

Number of Experts: Not applicable or explicitly stated. This is a comparison of technical characteristics and intended use to existing devices, not a study requiring expert readers to establish ground truth for a novel output.
Qualifications of Experts: N/A

4. Adjudication Method:

Adjudication Method: Not applicable. The process described is a regulatory review for substantial equivalence based on a comparison document and potentially internal test results, not a study involving human reader interpretation.

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

MRMC Study: No. This type of study is typically used for assessing the performance of diagnostic devices where human interpretation is involved. The Malibu Spinal System is an implantable surgical device.

6. Standalone Performance Study:

Standalone Study: Yes, in terms of mechanical strength. The document states "Mechanical Strength: See test results" for the Malibu Spinal System. While the full report is not included, this indicates that the device's mechanical properties were evaluated independently to demonstrate its performance, which was then compared to the predicate devices. The specific details of this testing (e.g., the exact criteria, methodology, and outcome beyond "similar") are not provided.

7. Type of Ground Truth Used:

Ground Truth: The "ground truth" for this submission is the established characteristics and performance of the predicate devices, as determined during their own regulatory approvals and market history. For the Malibu Spinal System's mechanical strength, the ground truth would be the measured physical properties and performance under specific test conditions, compared against the expected performance of the predicate devices.

8. Sample Size for the Training Set:

Training Set Sample Size: Not applicable. This is not a machine learning or AI device that would require a training set.

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

Ground Truth for Training Set Establishment: Not applicable.

Summary

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

JUL 1 2 2005

CONFIDENTIAL

Malibu Spinal System

510(K) SUMMARY

Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR § 807.92.

Submitter Information:	SeaSpine, Inc.Contact: Diana Smith2302 La Mirada DriveVista, CA 92081-7862Phone: 760-727-8399 Fax: 760-727-8809
Company Registration Number:	2032593
Submission Correspondent:	SeaSpine, Inc.Contact: Diana Smith, Manager ofRegulatory Affairs and Quality Assurance2302 La Mirada DriveVista, CA 92081-7862Phone: 760-727-8399 Fax: 760-727-8809
Date Summary Prepared:	June 15, 2005
Classification Name:	Pedicle Screw Spinal SystemMNH (Class II) - 888.3070(b)(1)MNI (Class II) - 888.3070(b)(1)NKB (Class III) -- 888.3070(b)(2)Spinal Interlaminal Fixation OrthosisKWP (Class II) – 888.3050
Common/Usual Name:	Iliac Monoaxial Screws, Monoaxial Screws,Fixed locking caps, Rods, Hooks,Components, and Instruments
Device Trade Name:	Malibu Spinal System

The devices used for comparison in this summary are Synthes Spine Company's Synthes Click'X Monoaxial Screw System (K031175), DePuy Acromed's Moss Miami System (K002607 and K992168) and SeaSpine Inc.'s UCR Spinal System (K993503, K021623, K031381, K032739/S1 and K043232).

(The statements of intended use are identical.) 1. Intended Use:

The intended use of the Malibu Spinal System iliac monoaxial screws, monoaxial screws, fixed locking caps, rods, hooks, and components, is substantially equivalent to the intended use of the predicate devices. The intended use of the Malibu Spinal

ge 1 of 4

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

Malibu Spinal System

System is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally . mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
spondylolisthesis, .
trauma (i.e., fracture or dislocation), .
spinal stenosis. ●
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
. spinal tumor,
pseudoarthrosis, and/or .
failed previous fusion. .

The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:

degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
spondylolisthesis .
trauma (i.e., fracture or dislocation), ◆
◆ spinal stenosis,
. deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
tumor, .
pseudarthosis, and/or .
failed previous fusion. .

2. Description:

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

Malibu Spinal System

be part of the Malibu system, but are compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.

3. Technological Characteristics:

The iliac monoaxial screws, monoaxial screws, fixed locking caps, rods, hooks, components, and instruments in this notification are components of a new stand alone system called Malibu Spinal System, but are designed to be compatible with and work in conjunction with the components in the current SeaSpine UCR Spinal System. The devices in this submission have substantially equivalent technological characteristics to the predicate devices. Refer to Table 1 in the following section, entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, and material.

4. Comparison Analysis:

The overall designs of the Malibu Spinal System iliac monoaxial screws, monoaxial screws, fixed locking caps, rods, hooks, and components are substantially equivalent to the predicate devices. See Table 1 on the following page for a comparison of the Malibu Spinal System iliac monoaxial screws, monoaxial screws, fixed locking caps, rods, hooks, and components to the predicate devices.

22
3 of 4

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

Malibu Spinal System

Feature	Malibu Spinal System	SynthesClick'XMonoaxialSystem	Moss MiamiSpinal System	SeaSpine UCRSpinal System	SubstantiallyEquivalent
Intended Use	The intended use of theMalibu Spinal System is asa temporary or permanentposterior, non-cervicalimplant to correct spinaldisorders and providestabilization of the spine topermit the biologicalprocess of spinal fusions tooccur	Similar	Similar	Similar	Yes
Indications forUse	• Degenerative disc disease(DDD) as defined by backpain of discogenic originwith degeneration of thedisc confirmed by patienthistory and radiographicstudies,• spondylolisthesis,• trauma (i.e., fracture ordislocation),• spinal stenosis,• deformities or curvatures(i.e., scoliosis, kyphosis,and/or lordosis),• tumor,• pseudarthosis, and/or• failed previous fusion.	Similar	Similar	Similar	Yes
Design	Iliac monoaxial screws,monoaxial screws, fixedlocking caps, rods, hooks,and components	Similar	Similar	Similar	Yes
lliacMonoaxialScrews	See prints	Similar	Similar	Similar	Yes
MonoaxialScrews	See prints	Similar	Similar	Similar	Yes
Caps	See prints	Similar	Similar	Similar	Yes
LaminarHooks	See prints	Similar	Similar	Similar	Yes
Pedicle Hooks	See prints	Similar	Similar	Similar	Yes
Offset Hooks	See prints	Similar	Similar	Similar	Yes
Material	Titanium alloy	Similar	Similar	Similar	Yes
Sterile	Non-sterile	Similar	Similar	Similar	Yes
Method ofSterilization	High-temperature steam	Similar	Similar	Similar	Yes
MechanicalStrength	See test results	Similar	Similar	Similar	Yes

Table 1: Summary of Design Comparison

િહ્મુદ

પ્

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three heads, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

JUL 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Diana Smith Manager of Regulatory Affairs and Quality Assurance SeaSpine, Inc. 2302 La Mirada Drive Vista, California 92081-7862

Re: K051663

Trade/Device Name: Malibu Spinal System Regulation Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis Regulatory Class: III Product Code: MNH, MNI, KWP, and NKB Dated: June 15, 2005 Received: June 24, 2005

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Ilsting 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 (PMA), 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{5}------------------------------------------------

Page 2 – Ms. Diana Smith

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in your le FDA finding of substantial equivalence of your device to a legally prematics notificate 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Atyt Clurdes
Miriam Provost, Ph.D.

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

Enclosure

{6}------------------------------------------------

Malibu Spinal System

Indications for Use Statement

510(k) Number (if known): K051663

Device Name: Malibu Spinal System

Indications for Use:

The intended use of the Malibu Spinal System, iliac monoaxial screws, monoaxial I he intended use of the Manbu Dpinal Upinial Upinianta, is substantially equivalent screws, fixed lockling Caps, fous, nooks, and vehipensial - 7 the Malibu Spinal
to the intended use of the predicate device. The intended used immlem to correct to the intended use of the products corrector, non-cervice implant to correct System is as a temporary of permatelli posteries, and the biological process of spinal fusions to occur.

The intended use of the Malibu Spinal System, when used as a Pedice Screw The intended use of the Manbu Spinal System Device System, is to provide Spillal System or Spondylonstiteers Enal segments in skeletally mature patients as immountzanon and staombation of the following acute and chronic instablities an adjulier to fusion in the treatments of and sacral spine. The indications for use are as follows:

degenerative disc disease (DDD) as defined by back pain of discogenic origin . degeneration of the discuse (222) nfirmed by patient history and radiographic studies,
studios,
severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally ● severe spondylonomons ( Liaions by autogenous bone graft having implants mature patients Tooering Tastener of ine (L3 to sa crum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
spondylolisthesis, ●
trauma (i.e., fracture or dislocation), .
spinal stenosis, .
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
spinal tumor, .

Prescription Use	X
(Part 21 CFR 801 Subpart D)
	AND/OR
	Over-The-Counter-Use
	(21 CFR 807 Subpart C)

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

(Division Sign Off) Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

510(k) Number	K051663
---------------	---------

{7}------------------------------------------------

Indications for Use Statement continued

pseudoarthrosis, and/or .
failed previous fusion. .

The intended use and indications of the Malibu Spinal System, when used as a The Interlaminal Fixation Orthosis or Hook Spinal System, are limited to Ti-L5 and are as follows:

rate as follows:
degenerative disc disease (DDD) as defined by back pain of discogenic origin . degenerative discuss (2) ===================================================================================================================================================== studies,
spondylolisthesis .
trauma (i.e., fracture or dislocation), .
spinal stenosis, .
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), .
. tumor,
pseudarthosis, and/or .
failed previous fusion. ●

Prescription Use(Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter-Use(21 CFR 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 of General, Restorative,
and Neurological Devices

510(k) Number	K051663
---------------	---------

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.