Who is the manufacturer of STRYKER UNIVERSAL NEURO 3 SYSTEM?

Stryker filed the 510(k) submission for STRYKER UNIVERSAL NEURO 3 SYSTEM (K112557).

What is the FDA product code for STRYKER UNIVERSAL NEURO 3 SYSTEM?

GWO. It is classified under 21 CFR 882.5320 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for STRYKER UNIVERSAL NEURO 3 SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for STRYKER UNIVERSAL NEURO 3 SYSTEM?

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

Who can help prepare an FDA 510(k) submission like STRYKER UNIVERSAL NEURO 3 SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

STRYKER UNIVERSAL NEURO 3 SYSTEM

K112557 · Stryker · GWO · Jan 5, 2012 · Neurology

Device Facts

Record ID	K112557
Device Name	STRYKER UNIVERSAL NEURO 3 SYSTEM
Applicant	Stryker
Product Code	GWO · Neurology
Decision Date	Jan 5, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5320
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 Story

Stryker Universal Neuro 3 System provides cranial fixation solutions; includes implant module with various plates (straight, gap, 3D, shunt, box, burr hole covers) and screws. Plates are malleable for manual contouring; low-profile design reduces palpability. Used in clinical settings by surgeons for cranial reconstruction/stabilization. System components are made of titanium; screws feature self-drilling/self-tapping designs. Output is rigid fixation of cranial flaps. Benefits include stabilization of non-load-bearing cranial areas and decreased palpability post-surgery.

Clinical Evidence

Bench testing only. Biocompatibility confirmed per ISO 10993-1, 10993-12, and 10993-18. Mechanical testing included bending stability (ASTM F 382-99) for plates/covers and torque, depth, angle, and pull-out safety testing (ASTM F 543) for screws. All acceptance criteria met.

Technological Characteristics

Materials: Commercially Pure Titanium (Grade II, IV, and V). Design: Low-profile plates, burr hole covers, and screws. Standards: ASTM F 382-99 (plates), ASTM F 543 (screws), ISO 10993 (biocompatibility). Surface treatment: Type III Anodization. Connectivity: None (mechanical implant system).

Indications for Use

Indicated for reconstruction, stabilization, and rigid fixation of non-load-bearing bony areas following craniotomy, craniectomy, and cranial fractures in adults and adolescents (age 12+). Contraindicated in non-reducible/unstable fractures, active local infections, metal allergies/foreign body sensitivity, non-compliant patients, poor bone quality/blood supply, or cases where implants/screws contact dura mater or developing paranasal sinuses.

Regulatory Classification

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.

Predicate Devices

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

Related Devices

K131775 — UNIVERSAL NEURO 3 SYSTEM · Stryker · Oct 17, 2013
K122049 — NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM · Kinamed, Inc. · Apr 5, 2013
K141644 — INNOVASIS CRANIAL SYSTEM · Innovasis, Inc. · Nov 7, 2014
K120352 — STRYKER QUIKFLAP STERILE PROCEDURE PACK · Stryker · Jun 11, 2012
K161821 — Stryker Universal Mesh · Stryker · Dec 8, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ KII2557. 7 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 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). #### 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 . {1}------------------------------------------------ - . 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 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. #### 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. 8 {2}------------------------------------------------ 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 9 {3}------------------------------------------------ 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. 10 ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {4}------------------------------------------------ | Universal Neuro III | Universal Neuro II | Synthes Matrix Neuro | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 53-34164 STRAIGHT PLATE, 16 HOLE 53-34804 STRAIGHT PLATE, 8 HOLE 53-34406 STRAIGHT PLATE, 4 HOLE W/BAR 53-36212 2 HOLE, RIGID, 12mm BAR 53-34212 2 HOLE W/TAB, 12mm BAR 53-34216 2 HOLE, 16mm BAR 53-34228 BOX PLATE, SMALL 53-34230 BOX PLATE, LARGE, W/TAB 53-34240 BOX PLATE, LARGE 53-34300 RECTANGLE PLATE 53-34812 GAP PLATE, 5 HOLE, SMALL 53-34522 GAP PLATE, 8 HOLE, LARGE 53-34608 DOUBLE-Y PLATE, 6-HOLE, W/BAR 53-34630 X PLATE, 4 HOLE 53-00362 MESH PLATE ROUND, SMALL 53-00364 MESH PLATE ROUND, MEDIUM 53-00466 MESH PLATE ROUND, LARGE 53-00342 TRANSLABYRINTHINE PLATE, SMALL 53-00346 TRANSLABYRINTHINE PLATE, LARGE 53-00324 TEMPORAL PLATE, MEDIUM 53-00382 SUBOCCIPITAL PLATE, SMALL 53-00486 SUBOCCIPITAL PLATE, LARGE | 53-05164 STRAIGHT PLATE, 16 HOLE 53-05804 STRAIGHT PLATE, 8 53-05406 STRAIGHT PLATE, 4 HOLE W/BAR 53-06212 2 HOLE, RIGID, 12mm BAR 53-05212 2 HOLE, W/TAB, 12mm BAR 53-05216 2 HOLE, 16mm BAR 53-05228 BOX PLATE, SMALL 53-05230 BOX PLATE, LARGE, W/TAB 53-05240 BOX PLATE, LARGE 53-05812 GAP PLATE, 6 HOLE, SMALL 53-05622 GAP PLATE, 6 HOLE, LARGE 53-05608 DOUBLE-Y PLATE 6HOLE, W/BAR 53-05630 X PLATE, 4 HOLE 54-00344 Dynamic mesh 40x40x0.3mm 54-00346 Dynamic mesh 90x90x0.3mm 54-00345 Dynamic mesh 120x120x0.3mm 54-00645 Dynamic mesh 40x40x0.6mm 54-00646 Dynamic mesh 90x90x0.6mm 54-00647 Dynamic mesh 120x120x0.6mm | 04 503 072 Adaption Plate, 20 holes 04.503 071 Adaption Plate, 7 holes 04 503 070 Adaption Plate, 5 holes 04 503.062 Straight Plate 2 holes, 12mm 04 503 063 Craniel Plate, straight, with centre space, 12 mm, 4 holes 04 503 065 Frame Plate, square, 4 holes, 14x14 mm 04 503 068 Frame Plate, square, 4 holes, 16x16 mm 04 503 073 Frame Plate, rectangular, 4 holes, 10x16 mm 04 503 074 Strut Plate, 2x3 holes, 14x24 mm 04 503 075 Strut Plate, 2x4 holes, 14x34 mm 04 503 068 Double-Y-Plate, 6 holes, length 18 mm 04 503 069 Double-Y-Plate, 6 holes, length 21 mm 04 503 064 X-Plate 4 holes 04 503 090 Circular, 30x0.4mm, malleable 04 503 091 Circular, 70x0.4mm, malleable 04 503 092 Circular, 100x0.4mm, malleable 04 503 093 Circular, 30x0.4mm, rigid 04 503 094 Circular, 70x0.4mm, rigid 04 503 095 Circular, 100x0.4mm, rigid 04 503 096 Mastoid Plate small 04 503.097 Mastoid Plate, medium 04 503.098 Mastoid Plate large 04 503.057 Temporal Mesh Plate, contourable, 0.4mm 04 503 086 Crescent-shaped, small, 0.4mm, malleable 04 503 087 Crescent-shaped, large, 0.4mm, malleable 04 503 088 Crescent-shaped, small, 0.4mm, rigid 04 503 089 Crescent-shaped, large, 0.4mm, rigid | | | | Stryker Leibinger GmbH & Co. KG, Facility in Joseph-Lang- Str. 22, 78570 Muentherm an der Donau, GER acc to new 510k number | Stryker Leibinger GmbH & Co KG Facility in Joseph-Lang- Str. 22, 78570 Muehlheim an der Donau, GER K031659, K983528 | Synthes (USA), 1101 Synthes Avenue, Monument, CO 80132 For Universal Neuro II: Equivalent manufacturer (Stryker/ Stetten) on the equivalent machines using the equivalent machine environment K022012 | | | | The Stryker Universall Neuro III implant system is intended for reconstruction, stabilization and/or rigid fixation of non load- bearing bony areas subsequent to praniotomy, cranicectomy and cranial fractures in adults and adolescents (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 craniofacial fractures and reconstruction in non-load bearning areas. | The Synthes Matrox Neuro Plate and screw System is intended for use in selective trauma of the midface and craniofacial skeleton, craniofacial surgery reconstructive procedures, and selective 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 | | | | | | | | | | Size Rectangular Plates X & Y Plates | Size | | | | | 53-34228 BOX PLATE, SMALL, 12x12mm 53-34230 BOX PLATE, LARGE, W/TAB, 16x16mm 53-34240 BOX PLATE LARGE, 16x16mm 53-34300 RECTANGLE PLATE, 12x16mm 53-34617 GAP PLATE, 6 HOLE SMALL, 14x26mm 53-34622 GAP PLATE, 6 HOLE, LARGE, 14x46mm | 53-05228 BOX PLATE, SMALL 12x12mm 53-05230 BOX PLATE, LARGE, W/TAB, 16x16mm 53-05240 BOX PLATE LARGE 16x16mm 53-05612 GAP PLATE, 6 HOLE, SMALL, 14x28mm 53-05612 GAP PLATE, 6 HOLE, SMALL, 14x28mm | 04 503.065 Frame Plate, square, 4 holes, 14x14 mm 04 503 066 Frame Plate, square, 4 holes, 16x16 mm 04 503 073 Frame Plate, rectangular, 4 holes, 10x16 mm 04 503.074 Strut Plate, 2x3 holes 14x24 mm 04 503 075 Strut Plate 2x4 holes 14x34 mm | | | | 53-34608 DOUBLE-Y PLATE, 6-HOLE, W/BAR, 11x19mm 53-34630 X PLATE, 4 HOLE, 17x17mm | 53-05608 DOUBLE-Y PLATE, 6-HOLE, W/BAR, 10x18mm 53-05630 X PLATE, 4 HOLE, 17x17mm | 04.503 068 Double-Y-Plate, 6 holes length 18 mm 04.503.069 Double-Y-Plate, 6 holes, length 21 mm 04 503 084 X-Plate 4 holes | | | | Countersunk | | | | | | | | The shape of the countersunk is widened by means of the diameter at the lower opening. Due to the Universal Neuro III screw head diameter of 2.7mm the screw is not endangered to fall through the 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. The 0.6mm 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 Plates Round shaped | | | | | | 53-00362, Ø41.5mmx0.3mm 53-00364, Ø46.6mmx0.3mm 53-00466, Ø57.6mmx0.4mm | 54-00344: Dynamic mesh 40x40x0.3mm 54-00346: Dynamic mesh 90x90x0.3mm 54-00345: Dynamic mesh 120x120x0.3mm 54-00645 Dynamic mesh 40x40x0.6mm 54-00646: Dynamic mesh 90x90x0.6mm 54-00647: Dynamic mesh 120x120x0.6mm | 04 503 090 Circular, 30x0.4mm, malleable 04 503 091 Circular, 70x0.4mm, malleable 04 503 092 Circular, 100x0.4mm, malleable 04 503 093 Circular, 30x0.4mm, rigid 04 503 094 Circular, 70x0.4mm, rigid 04 503 095 Circular, 100x0.4mm, rigid | | | | Size Translabyrinthine Plates Triangular shaped | | | | | | 53-00342: 54.3x51.9x0.3mm 53-00346: 60.3x59.9x0.3mm | | 04.503 096 Mastoid Plate, small 04 503.097 Mastoid Plate, medium 04.503.098 Mastoid Plate, large | | The shape of the Universal Neuro III Skull Base subject devices is equivalent to the ones offered by the predicate devisee from Synthes | | Internal Mesh Pattern Temporal Plate Bean shape | | | | The outer dimensions of the Universal Neuro III Skull Base subject devices is within the range offered by both predicate devices | | 53-00324 47x29x0.3mm | | 04 503.057 Temporal Mesh Plate, contourable, 0.4mm | | | | Suboccipital Plates Trapecial shaped | | | | | | 53-00382: 61.8x32.1x0.3mm 53-00486: 65.4x41.5x0.4mm…