The Stryker Universal Neuro 3 System is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).

Device Description

The Stryker Universal Neuro 3 System is designed for a wide selection of solutions for cranial fixation. It consists of an implant module (a storage module that contains various versions and shapes of plates and screws) for the respective anatomical and indicated areas. The low profile plates of the Stryker Universal Neuro 3 System provide rigid fixation of cranial flaps with decreased palpability. There is a comprehensive selection of burr hole covers, straight plates, gap plates, 3D-plates, shunt plates, and box plates to provide many fixation options. The malleable plates can be easily contoured by hand without instruments. The pre-shaped skull-base plates provide covers for standard craniectomies, obviating the need to cut or trim mesh.

AI/ML Overview

The Stryker Universal Neuro 3 System is intended for reconstruction, stabilization, and/or rigid fixation of non-load-bearing bony areas subsequent to craniotomy, craniectomy, and cranial fractures in adults and adolescents (age 12 and higher).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1 (biological evaluation), ISO 10993-12 (sample preparation), ISO 10993-18 (chemical characterization).	Materials used are rated biocompatible according to ISO 10993-1. Cytotoxicity testing was performed according to ISO 10993-1, 10993-12, and 10993-18.
Corrosion Resistance	Demonstrated corrosion resistance of all components.	The corrosion resistance of all Neuro 3 screws, plates, and meshes were demonstrated.
Bending Stability	Plates (GWO) and burr hole covers (GXR) must pass the Lerch test according to ASTM F 382-99.	The bending stability of the Universal Neuro 3 plates (GWO) and burr hole covers (GXR) were tested by following ASTM F 382-99. The Lerch test was passed by all plates.
Screw Performance	Screws (HBW) must meet ASTM F 543 standards for metallic medical bone screws, including torque, depth, and angle measurements.	Testing was performed via ASTM F 543. Torque, depth, and angle were measured. The screws passed the automated insertion test.
Fixation Stability	Screws must demonstrate pull-out safety.	Pull-out safety testing was performed utilizing ASTM F 543. All acceptance criteria were met.
Retention Force	The retention force between the screw and the screwdriver blade must meet acceptance criteria.	Retention force between the screw and the screwdriver blade was tested utilizing ASTM F 543. All acceptance criteria were met.
Substantial Equivalence	Demonstrated substantial equivalence to identified predicate devices (Stryker Universal Neuro 2 System, Stryker Micro Dynamic Mesh, Synthes Neuro Plate and Screw System, KLS-Martin Micro Osteosynthesis System).	The Stryker Universal Neuro 3 System was verified and validated according to Stryker procedures. It was found substantially equivalent to predicate devices, sharing material composition, operating principles, and similar intended use (with the addition of adolescent use). Minor differences in dimensions and shapes were addressed.

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

The document does not specify exact "sample sizes" in terms of number of devices tested for each performance criterion. Instead, it refers to testing of "all plates," "the screws," and "all Neuro 3 screws, plates and meshes." This implies that a sufficient number of samples were tested to demonstrate compliance with the referenced ASTM and ISO standards for the representative product configurations.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests were conducted according to recognized international (ISO) and US (ASTM) standards, suggesting the testing was performed in a controlled laboratory environment to demonstrate compliance. Given the context of a 510(k) submission, this testing would be prospective and specifically conducted for regulatory approval.

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

This information is not applicable to this type of device and study. The testing for the Stryker Universal Neuro 3 System involves mechanical and material property evaluations against established engineering standards (ASTM, ISO), not clinical assessment requiring expert interpretation of data or images. Therefore, there is no "ground truth" to be established by experts in a clinical sense.

4. Adjudication method for the test set

This information is not applicable for the reasons stated above. Adjudication methods are typically used in studies involving subjective interpretation, such as clinical trials or image-based diagnostic assessments.

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

There was no MRMC comparative effectiveness study done. This device is a passive implant (craniofacial plates, burr hole covers, and screws) and does not involve AI or human "readers" in its function or evaluation for regulatory submission.

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

There was no standalone (algorithm only) performance study done. This device is a physical medical implant and does not involve any algorithms or software for its primary function.

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

The "ground truth" for this device's performance evaluation is based on established engineering standards and material specifications. For example:

Biocompatibility: Conformance to ISO 10993 series.
Mechanical Properties: Conformance to ASTM F 382-99 for bending stability (Lerch test) and ASTM F 543 for screw performance (torque, depth, angle, pull-out safety, retention force).
Material Composition: Commercially Pure Titanium (Grade II, IV) and Titanium Alloy (Grade V), which are well-defined materials with known properties.

These standards and specifications serve as the objective "ground truth" against which the device's performance is measured.

8. The sample size for the training set

There is no training set for this device. As a passive mechanical implant, it does not involve machine learning or AI models that require training data.

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

This question is not applicable as there is no training set or ground truth established for a training set for this device.

Summary

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KII2557.

JAN - 5 2012

510(k) Summary of Safety and Effectiveness

Stryker Universal Neuro 3 System Proprietary Name: Neuro Plating System Common Name: Classification Name and Reference: Preformed alterable cranioplasty plate 21 CFR §882.5320 Burr hole cover 21 CFR §882.5250 Cranioplasty plate fastener 21 CFR §882.5360 Class II Proposed Regulatory Class: GWO - Preformed alterable cranioplasty plate Product Codes: GXR - Burr hole cover HBW - Cranioplasty plate fastener Rob Yamashita For Information contact: Sr. Regulatory Compliance Analyst Stryker Craniomaxillofacial 750 Trade Centre Way, Suite 200 Portage, MI 49002 Phone: (269) 389-4258 / Fax: (269) 329-2235 rob. yamashita@stryker.com

Date Prepared:

September 1, 2011

Indications for Use / Intended Use

Contraindications

The Stryker Universal Neuro 3 System is contraindicated for the following:

Use of plates in non-reducible and unstable fractures .
Patients with active local infections .
Patients with metal allergies and foreign body sensitivity .

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. Potentially non-compliant patients with mental or neurological conditions who are unwilling or incapable of following postoperative care instructions
. Patients with limited blood supply to, or insufficient quality of, bone
. Use of products in cases where the fixation of the products could result in their peripheral edge coming into contact with the dura mater
. Screws coming in contact with the dura mater
. Use of implants adjacent to developing paranasal sinuses

Technological Characteristics

The low profile plates of the Stryker Universal Neuro 3 System provide rigid fixation of cranial flaps with decreased palpability. There is a comprehensive selection of burr hole covers, straight plates, gap plates, 3D-plates, shunt plates, and box plates to provide many fixation options. The malleable plates can be easily contoured by hand without instruments. The pre-shaped skull-base plates provide covers for standard craniectomies, obviating the need to cut or trim mesh.

Performance Data

Materials used for the Stryker Universal Neuro 3 System are the same as the predicate devices. This includes all three product codes (GWO, GXR and HBW). The titanium materials used for manufacturing of the Stryker Universal Neuro 3 implants are rated to be biocompatible according to ISO 10993-1. Cytotoxicity testing was performed according to ISO 10993-1, 10993-12, and 10993-12, and 10993-18. The corrosion resistance of all Neuro 3 screws, plates and meshes were demonstrated.

The bending stability of the Universal Neuro 3 plates (product code GWO) and burr hole covers (product code GXR) were tested by following ASTM F 382-99. The Lerch test was passed by all plates.

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For the screws (product code HBW), the testing was performed via ASTM F 543 -Standard Specification and Test Methods for Metallic Medical Bone Screws, 2007. Torque, depth and angle were measured. The screws passed the automated insertion test.

Additionally, we tested the fixation stability of our screws with pull out safety testing and the retention force between the screw and the screwdriver blade also utilizing ASTM F 543. All acceptance criteria were met.

Substantial Equivalence

The Stryker Universal Neuro 3 System has been verified and validated according to Stryker procedures for product design and development. The validation proves the safety and effectiveness of the system. The information provided by Stryker in this 510(k) application was found to be substantially equivalent with these predicate devices:

Stryker Universal Neuro 2 System (Stryker, K031659) .
Stryker Micro Dynamic Mesh (Stryker, K983528) .
Synthes Neuro Plate and Screw System (Synthes, K022012) .
Osteosynthesis (KLS-Martin, . KLS-Martin Micro System K944561/K944565)

The Stryker Universal Neuro 3 System, as stated above, consists of devices with three product codes: GWO (plates), GXR (burr hole covers), and HBW (screws). It has the same material composition and operating principles as its predicates mentioned above. The intended use is similar to the predicate systems with the only difference being the inclusion of adolescent usc. Further, there may be slight differences in dimensions and shapes between the Stryker Universal Neuro 3 System and the predicate devices; however, the information provided in this 510(k) proves substantial equivalence to the predicate devices.

Specifically speaking, our Universal Neuro 3 burt hole covers and screws are substantially equivalent to Stryker Universal Neuro 2 System ( K031659) and

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Synthes Neuro Plate and Screw System (K022012). Our Universal Neuro 3 plates are substantially equivalent to the same two predicates named above (K031659 and K022012) plus Stryker Micro Dynamic Mesh (K983528). Also, we included the KLS-Martin Micro Osteosynthesis System (K944561/K944565) as a predicate because of its indicated pediatric use.

Below are three tables that outline our Universal Neuro 3 substantial equivalence.

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Universal Neuro III	Universal Neuro II	Synthes Matrix Neuro
53-34164 STRAIGHT PLATE, 16 HOLE53-34804 STRAIGHT PLATE, 8 HOLE53-34406 STRAIGHT PLATE, 4 HOLE W/BAR53-36212 2 HOLE, RIGID, 12mm BAR53-34212 2 HOLE W/TAB, 12mm BAR53-34216 2 HOLE, 16mm BAR53-34228 BOX PLATE, SMALL53-34230 BOX PLATE, LARGE, W/TAB53-34240 BOX PLATE, LARGE53-34300 RECTANGLE PLATE53-34812 GAP PLATE, 5 HOLE, SMALL53-34522 GAP PLATE, 8 HOLE, LARGE53-34608 DOUBLE-Y PLATE, 6-HOLE, W/BAR53-34630 X PLATE, 4 HOLE53-00362 MESH PLATE ROUND, SMALL53-00364 MESH PLATE ROUND, MEDIUM53-00466 MESH PLATE ROUND, LARGE53-00342 TRANSLABYRINTHINE PLATE, SMALL53-00346 TRANSLABYRINTHINE PLATE, LARGE53-00324 TEMPORAL PLATE, MEDIUM53-00382 SUBOCCIPITAL PLATE, SMALL53-00486 SUBOCCIPITAL PLATE, LARGE	53-05164 STRAIGHT PLATE, 16 HOLE53-05804 STRAIGHT PLATE, 853-05406 STRAIGHT PLATE, 4 HOLE W/BAR53-06212 2 HOLE, RIGID, 12mm BAR53-05212 2 HOLE, W/TAB, 12mm BAR53-05216 2 HOLE, 16mm BAR53-05228 BOX PLATE, SMALL53-05230 BOX PLATE, LARGE, W/TAB53-05240 BOX PLATE, LARGE53-05812 GAP PLATE, 6 HOLE, SMALL53-05622 GAP PLATE, 6 HOLE, LARGE53-05608 DOUBLE-Y PLATE 6HOLE, W/BAR53-05630 X PLATE, 4 HOLE54-00344 Dynamic mesh 40x40x0.3mm54-00346 Dynamic mesh 90x90x0.3mm54-00345 Dynamic mesh 120x120x0.3mm54-00645 Dynamic mesh 40x40x0.6mm54-00646 Dynamic mesh 90x90x0.6mm54-00647 Dynamic mesh 120x120x0.6mm	04 503 072 Adaption Plate, 20 holes04.503 071 Adaption Plate, 7 holes04 503 070 Adaption Plate, 5 holes04 503.062 Straight Plate 2 holes, 12mm04 503 063 Craniel Plate, straight, with centre space, 12 mm, 4 holes04 503 065 Frame Plate, square, 4 holes, 14x14 mm04 503 068 Frame Plate, square, 4 holes, 16x16 mm04 503 073 Frame Plate, rectangular, 4 holes, 10x16 mm04 503 074 Strut Plate, 2x3 holes, 14x24 mm04 503 075 Strut Plate, 2x4 holes, 14x34 mm04 503 068 Double-Y-Plate, 6 holes, length 18 mm04 503 069 Double-Y-Plate, 6 holes, length 21 mm04 503 064 X-Plate 4 holes04 503 090 Circular, 30x0.4mm, malleable04 503 091 Circular, 70x0.4mm, malleable04 503 092 Circular, 100x0.4mm, malleable04 503 093 Circular, 30x0.4mm, rigid04 503 094 Circular, 70x0.4mm, rigid04 503 095 Circular, 100x0.4mm, rigid04 503 096 Mastoid Plate small04 503.097 Mastoid Plate, medium04 503.098 Mastoid Plate large04 503.057 Temporal Mesh Plate, contourable, 0.4mm04 503 086 Crescent-shaped, small, 0.4mm, malleable04 503 087 Crescent-shaped, large, 0.4mm, malleable04 503 088 Crescent-shaped, small, 0.4mm, rigid04 503 089 Crescent-shaped, large, 0.4mm, rigid
Stryker Leibinger GmbH & Co. KG, Facility in Joseph-Lang-Str. 22, 78570 Muentherm an der Donau, GERacc to new 510k number	Stryker Leibinger GmbH & Co KG Facility in Joseph-Lang-Str. 22, 78570 Muehlheim an der Donau, GERK031659, K983528	Synthes (USA), 1101 Synthes Avenue, Monument, CO 80132For Universal Neuro II: Equivalent manufacturer (Stryker/ Stetten) on the equivalent machinesusing the equivalent machine environmentK022012
The Stryker Universall Neuro III implant system is intended forreconstruction, stabilization and/or rigid fixation of non load-bearing bony areas subsequent to praniotomy, cranicectomyand cranial fractures in adults and adolescents (age 12 andhigher)	The Stryker Leibinger Universal Neuro System is a low-profileplate and screw system intended for osteotomy, craniotomystabilization and rigid fixation of craniofacial fractures andreconstruction in non-load bearning areas.	The Synthes Matrox Neuro Plate and screw System is intendedfor use in selective trauma of the midface and craniofacialskeleton, craniofacial surgery reconstructive procedures, andselective orthognatic surgery of the maxilla and chin.
Neuro (Cranial)	Craniotacial	Neuro (Cranial), Midface, Maxilla & Chin
Commercially Pure Titanium, Grade II and IV	Commercially Pure Titanium, Grade II and IV	Commercially Pure Titanium

SizeRectangular PlatesX & Y Plates	Size
53-34228 BOX PLATE, SMALL, 12x12mm53-34230 BOX PLATE, LARGE, W/TAB, 16x16mm53-34240 BOX PLATE LARGE, 16x16mm53-34300 RECTANGLE PLATE, 12x16mm53-34617 GAP PLATE, 6 HOLE SMALL, 14x26mm53-34622 GAP PLATE, 6 HOLE, LARGE, 14x46mm	53-05228 BOX PLATE, SMALL 12x12mm53-05230 BOX PLATE, LARGE, W/TAB, 16x16mm53-05240 BOX PLATE LARGE 16x16mm53-05612 GAP PLATE, 6 HOLE, SMALL, 14x28mm53-05612 GAP PLATE, 6 HOLE, SMALL, 14x28mm	04 503.065 Frame Plate, square, 4 holes, 14x14 mm04 503 066 Frame Plate, square, 4 holes, 16x16 mm04 503 073 Frame Plate, rectangular, 4 holes, 10x16 mm04 503.074 Strut Plate, 2x3 holes 14x24 mm04 503 075 Strut Plate 2x4 holes 14x34 mm
53-34608 DOUBLE-Y PLATE, 6-HOLE, W/BAR, 11x19mm53-34630 X PLATE, 4 HOLE, 17x17mm	53-05608 DOUBLE-Y PLATE, 6-HOLE, W/BAR, 10x18mm53-05630 X PLATE, 4 HOLE, 17x17mm	04.503 068 Double-Y-Plate, 6 holes length 18 mm04.503.069 Double-Y-Plate, 6 holes, length 21 mm04 503 084 X-Plate 4 holes
Countersunk
		The shape of the countersunk is widened by means of the diameter at the lower opening. Due tothe Universal Neuro III screw head diameter of 2.7mm the screw is not endangered to fall throughthe plate hole
Thickness	0.6mm (1 "rigid" plate) and 0.4mm (all others)	0.6mm (1 "rigid" plate) and 0.5mm (all others)	0.4mm	The thickness of the 0.4mm subject devices is equivalent to the Synthe spredicate devices. The0.6mm subject device is equivalent to the 0.6mm Universal Neuro II device
Surface treatment	Type III Anodization	Type III Anodization	n/a	Equivalent surface treatment of Universal Neuro II and III devices.
Round Mesh PlatesRound shaped
53-00362, Ø41.5mmx0.3mm53-00364, Ø46.6mmx0.3mm53-00466, Ø57.6mmx0.4mm	54-00344: Dynamic mesh 40x40x0.3mm54-00346: Dynamic mesh 90x90x0.3mm54-00345: Dynamic mesh 120x120x0.3mm54-00645 Dynamic mesh 40x40x0.6mm54-00646: Dynamic mesh 90x90x0.6mm54-00647: Dynamic mesh 120x120x0.6mm	04 503 090 Circular, 30x0.4mm, malleable04 503 091 Circular, 70x0.4mm, malleable04 503 092 Circular, 100x0.4mm, malleable04 503 093 Circular, 30x0.4mm, rigid04 503 094 Circular, 70x0.4mm, rigid04 503 095 Circular, 100x0.4mm, rigid
SizeTranslabyrinthine PlatesTriangular shaped
53-00342: 54.3x51.9x0.3mm53-00346: 60.3x59.9x0.3mm		04.503 096 Mastoid Plate, small04 503.097 Mastoid Plate, medium04.503.098 Mastoid Plate, large		The shape of the Universal Neuro III Skull Base subject devices is equivalent to the ones offeredby the predicate devisee from Synthes
Internal Mesh PatternTemporal PlateBean shape				The outer dimensions of the Universal Neuro III Skull Base subject devices is within the rangeoffered by both predicate devices
53-00324 47x29x0.3mm		04 503.057 Temporal Mesh Plate,contourable, 0.4mm
Suboccipital PlatesTrapecial shaped
53-00382: 61.8x32.1x0.3mm53-00486: 65.4x41.5x0.4mm		04 503 086 Crescent-shaped,small, 0.4mm, malleable04 503 087 Crescent-shaped,large, 0.4mm, malleable04 503 088 Crescent-shaped,small, 0.4mm, rigid04.503 089 Crescent-shaped,large, 0.4mm, rigid		The pattern of the subject devices as well as all predicate devices is equivalent characterized byfixation holes surrounded by connecting bars
ThicknessSurface treatment	1.3mm and 0.4mmType III Anodization	0.3mm and 0.6mmType III Anodization	0.4mm and 0.6mm	The pattern holes are of equivalent dimensions between the Universal Neuro III subject devicesand the Universal Neuro II predicate devices. The hole connecting bars of the Universal Neuro IIIsubject devices are wider than the ones of the Universal Neuro II predicate devices offering morestability
				The thickness of the Universal Neuro III Skull Base subject devices is within the range offered byboth predicate devices
				Equivalent surface treatment of Universal Neuro II and III devices.
DeviceName	SubjectDeviceUniversal Neuro III	SubjectDeviceUniversal Neuro II	Synthes Matrix Neuro	Similarities / Differences
DevicePartNumbers	53-34507: 7mm Burr Hole Cover53-34510: 10mm Burr Hole Cover53-34514: 14mm Burr Hole Cover53-34520: 20mm Burr Hole Cover53-34524: 24mm Burr Hole Cover53-34614: 14mm Shunt53-34620: 20mm Shunt	53-05507: 7mm Burr Hole Cover53-05510: 10mm Burr Hole Cover53-05514: 14mm Burr Hole Cover53-05520: 20mm Burr Hole Cover	04.503.021; 12mm Burr Hole Cover04.503.022: 15mm Burr Hole Cover04.503.023 17mm Burr Hole Cover04.503.024: 24mm Burr Hole Cover04.503.026: 12mm Shunt04.503.027: 15mm Shunt04.503.028: 17mm Shunt04.503.029. 24mm Shunt	n/a
Manufacturer	Stryker Leibinger GmbH & Co. KG, Facility in Joseph-Lang-Str. 22, 78570 Muehlheim an der Donau, GER	Stryker Leibinger GmbH & Co. KG, Facility in Joseph-Lang-Str. 22, 78570 Muehlheim an der Donau, GER	Synthes (USA), 1101 Synthes Avenue, Monument, CO80132	For Universal Neuro II: Equivalent manufacturer (Stryker/ Stetten) on the equivalent machinesusing the equivalent machine environment.
510(k)	acc to new 510k number	K031659	K022012	n/a
Intended Use	The Stryker® Universal Neuro III implant system is intendedfor reconstruction, stabilization and/or rigid fixation of nonload-bearing bony areas subsequent to craniotomy,cranioectomy and cranial fractures in adults andadolescents (age 12 and higher).	The Stryker Leibinger Universal Neuro System is a low-profile plate and screw system intended for osteotomy,craniotomy, stabilization and rigid fixation of craniofacialfractures and reconstruction in non-load bearing areas,	The Synthes Matrix Neuro Plate and screw System isintended for use in selective trauma of the midface andcraniofacial skeleton; craniofacial surgery; reconstructiveprocedures; and selective orthognathic surgery of the maxillaand chin.	The subjected device is intended to be used in cranial areas which are similar to thepredicates. But it is limited to non-load bearing cranial indications only, whereas the Synthespredicate indications cover facial/orbital or mandibular sites as well. Additionally the subject isintended to be used in adolescents and adults whereas the predicates have no limitation tothis.
Application Area	Neuro (Cranial)	Craniofacial	Neuro (Cranial), Midface, Maxilla & Chin	For Universal Neuro II: Equivalent application area compared to Universal Neuro IIIFor Synthes: Enhanced application area including the one of Universal Neuro III
Material	Commercially Pure Titanium	Commercially Pure Titanium	Commercially Pure Titanium	Equivant material, therefore all plates are equal in regard to the mechanical and chemicalproperties of their material,
Design	Image: Burrhole Cover	Image: Shunt Plates	Image: Burrhole Cover	n/a
Countersink	Image: Countersink	Image: Countersink	Image: Countersink	The subjected devices are of equivalent choice of sizes as available for the predicate devises.The number for countersinks for screw insertion of the subject devices are equivalent to theones of the Synthes predicte devices.
Thickness	0.4mm	0.5mm	0.4mm	The shape of the countersink is widened by means of the diameter at the lower opening. Dueto the Universal Neuro III screw head diameter of 2.7mm the screw is not endangered to fallthrough the plate hole.
Surface treatment	Type III Anodization	Type III Anodization	n/a	The thickness of the subject devices is equivalent to the Synthe spredicate devices.Equivalent surface treatment of Universal Neuro li and III devices.
Constitutional PrinciplesSurgical Technique/SitePreparation	see intended use	see intended use	see intended use	see intended use

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Subject	Predicate	Synthes Matrix Neuro	Similarities / Differences
Stryker Universal Neuro III	Stryker Universal Neuro II		n/a
56-15903 1.5x3mm self drilling56-15904 1.5x4mm self drilling56-15905 1.5x5mm self drilling56-15004 1,5x4 mm sell tapping56-15005 1.5x5mm sell tapping56-15006 1.5x6mm sell tapping56-17304 1.7x4mm sell tapping emergency	50-15904 1.5x4mm self drilling50-15905 1,5x5mm sed dring50-15004 1,5x4mm selt tapping50-15005 1.5x5mm selt tapping50-15006 1.5x6mm sell tapping50-17304 1.7x4 man selt tapping emergency	04.503.103.01 1.5x3mm self drilling04.503.104.01 1,5x4mm self drilling04.503.105,01 1,5x5mm self drilling	n/a
Stryker Leibinger GmbH & Co. KG, Boetzinger Str. 41, 78111 Freiburg,GER	Stryker Leibinger GmbH & Co. KG, Boetzinger Str. 41, 79111 Freiburg,GER	Synthes (USA), 1101 Synthas Avenue, Monument, CO 80132
acc to new 510k numberK031659		K022012
Environment			For Universal Neuro II: Equivalent manufacturer (Stryker Freiburg) on theequivalent machines using the equivalent machine environment comparedto Universal Neuro II.
Intended Use			n/a
Indications for use			The Stryker® Universal Neuro III implant system as intended forreconstruction, stabilization and/or rigid fixation of non load-bearing bornyareas subsequent to craniotomy, cranicectomy and cranial fractures inadults and adolescents (age 12 and higher).	The Stryker Leibinger Universal Neuro System is a low-profile plate andscrew system intended for osteotomy, craniotomy, stabilization and rigidfoxation of craniofacial fractures and reconstruction in non-load bearingareas.		The Synthes Matrix Neuro Plate and screw System is intended for use inselective trauma of the midface and craniofacial skeleton; craniofacialsurgery, reconstructive procedures, and selective orthognatic surgery ofthe maxilla and chin.	The subject device is intended to be used in cranial areas which are similarto the predicates, But it is limited to non-load bearing cranial indicationsonly, whereas the Synthes predicate indications cover facial/orbital ormandibular sites as well. Additionally the subject is intended to be used inadolescents and adults whereas the predicates have no limitation to this.
Application Area			Neuro (Cranial)	Craniofacial	Neuro (Cranial), Midface, Maxilla & Chin	For Universal Neuro II: Equivalent application area compared to UniversalNeuro II.For Synthes: Enhanced application area including the one of UniversalNeuro III
Material			Titanium Alloy, Grade V	Titanium Alloy, Grade V	Titanium Alloy	Equivant material, therefore all screws are equal in regard to themechanical and chemical properties of their material.
Design						The design features of the screws are:-Head Geometry (outer shape): Reduced screw head heights &decreased cross slot widths and depths compared to Universal Neuro IIscrews; Verification/Validation testing proved safety of Universal Neuro IIdesign;-Core Diameter: Equivalent core diameter for Universal Neuro II and III selftapping screws and the 5mm self-drilling screws, increased core diameterfor Universal Neuro III 3mm and 4mm self drilling screws increasing thescrew stabilits compared to Universal Neuro II;-Length: Equivalent to the predicates except for Universal Neuro III 3mmself drilling screw which is not included in the Universal Neuro II system
Surface treatment			Type III Anodization			For Universal Neuro II: Equivalent surface treatment compared to UniversalNeuro III
Surgical Technique/Site			see intended use	see intended use		see intended use

Carolina Career Station

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Rob Yamashita Senior Regulatory Affairs Representative Stryker Craniomaxillofacial 750 Trade Centre Way, Suite 200 Portage, MI 49002

JAN - 5 2012

Re: K112557

Trade/Device Name: Stryker Universal Neuro 3 System Regulation Number: 21 CFR 882.5320 Regulation Name: Performed alterable cranioplasty plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: December 28, 2011 Received: December 29, 2011

Dear Mr. Yamashita:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. -- We remind you, however, that device labeling must-be-truthful and not-misleading. -

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regarding the reporting the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number: K112557

Device Name: Stryker Universal Neuro 3 System

Indications For Use:

The Stryker Universal Neuro 3 System is intended for reconstruction, stabilization and/or rigid fixation of non-load-bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).

Contraindications:

The Stryker Universal Neuro 3 System is contraindicated for the following:

Use of plates in non-reducible and unstable fractures ●
Patients with active local infections .
Patients with metal allergies and foreign body sensitivity .
Potentially non-compliant patients with mental or neurological conditions who are unwilling . or incapable of following postoperative care instructions
Patients with limited blood supply to or insufficient quality of bone .
Use of products in cases where the fixation of the products could result in their peripheral . edge coming into contact with the dura mater
Screws coming in contact with the dura mater .
Use of implants adjacent to developing paranasal sinuses .

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jit Brown

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

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510(k) Number K12557

Regulation Number and Section

§ 882.5320 Preformed alterable cranioplasty plate.

(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).