(125 days)
No
The device description and performance studies focus on the mechanical properties and materials of cranial fixation plates and screws, with no mention of AI or ML.
Yes
The device is described as being "intended for reconstruction, stabilization and/or rigid fixation" of cranial areas, which clearly indicates a therapeutic purpose. It consists of implants like plates and screws used to repair and stabilize the skull after injuries or surgeries.
No
The device is intended for reconstruction, stabilization, and rigid fixation following craniotomy, craniectomy, and cranial fractures, which are treatment procedures, not diagnostic ones.
No
The device description explicitly details physical components like plates, screws, and a storage module, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "reconstruction, stabilization and/or rigid fixation of non load-bearing areas subsequent to craniotomy, craniectomy and cranial fractures". This describes a surgical implant used to physically repair and stabilize bone structures.
- Device Description: The description details plates, screws, and burr hole covers, which are all physical components used in surgical procedures.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The information provided describes a surgical implant system, not an IVD.
N/A
Intended Use / Indications for 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).
Product codes
GWO, GXR, HBW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial
Indicated Patient Age Range
adults and adolescents (age 12 and higher)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
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.
Key Metrics
Not Found
Predicate Device(s)
K031659, K983528, K022012, K944561/K944565
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 | 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 | The pattern of the subject devices as well as all predicate devices is equivalent characterized by | |||
| fixation holes surrounded by connecting bars | ||||
| Thickness | ||||
| Surface treatment | 1.3mm and 0.4mm | |||
| Type III Anodization | 0.3mm and 0.6mm | |||
| Type III Anodization | 0.4mm and 0.6mm | The pattern holes are of equivalent dimensions between the Universal Neuro III subject devices | ||
| and the Universal Neuro II predicate devices. The hole connecting bars of the Universal Neuro III | ||||
| subject devices are wider than the ones of the Universal Neuro II predicate devices offering more | ||||
| stability | ||||
| The thickness of the Universal Neuro III Skull Base subject devices is within the range offered by | ||||
| both predicate devices | ||||
| Equivalent surface treatment of Universal Neuro II and III devices. | ||||
| Device | ||||
| Name | Subject | |||
| Device | ||||
| Universal Neuro III | Subject | |||
| Device | ||||
| Universal Neuro II | Synthes Matrix Neuro | Similarities / Differences | ||
| Device | ||||
| Part | ||||
| Numbers | 53-34507: 7mm Burr Hole Cover | |||
| 53-34510: 10mm Burr Hole Cover | ||||
| 53-34514: 14mm Burr Hole Cover | ||||
| 53-34520: 20mm Burr Hole Cover | ||||
| 53-34524: 24mm Burr Hole Cover | ||||
| 53-34614: 14mm Shunt | ||||
| 53-34620: 20mm Shunt | 53-05507: 7mm Burr Hole Cover | |||
| 53-05510: 10mm Burr Hole Cover | ||||
| 53-05514: 14mm Burr Hole Cover | ||||
| 53-05520: 20mm Burr Hole Cover | 04.503.021; 12mm Burr Hole Cover | |||
| 04.503.022: 15mm Burr Hole Cover | ||||
| 04.503.023 17mm Burr Hole Cover | ||||
| 04.503.024: 24mm Burr Hole Cover | ||||
| 04.503.026: 12mm Shunt | ||||
| 04.503.027: 15mm Shunt | ||||
| 04.503.028: 17mm Shunt | ||||
| 04.503.029. 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, CO | |||
| 80132 | For Universal Neuro II: Equivalent manufacturer (Stryker/ Stetten) on the equivalent machines | |||
| using 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 intended | |||
| for reconstruction, stabilization and/or rigid fixation of non | ||||
| load-bearing bony areas subsequent to craniotomy, | ||||
| cranioectomy 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 bearing areas, | The Synthes Matrix Neuro Plate and screw System is | |||
| intended for use in selective trauma of the midface and | ||||
| craniofacial skeleton; craniofacial surgery; reconstructive | ||||
| procedures; and selective orthognathic surgery of the maxilla | ||||
| and chin. | The subjected device is intended to be used in cranial areas which are similar to the | |||
| predicates. But it is limited to non-load bearing cranial indications only, whereas the Synthes | ||||
| predicate indications cover facial/orbital or mandibular sites as well. Additionally the subject is | ||||
| intended to be used in adolescents 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 Universal Neuro III |
| For 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 chemical |
| properties 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 the | ||||
| ones 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. Due |
| to the Universal Neuro III screw head diameter of 2.7mm the screw is not endangered to fall | ||||
| through 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 Principles | ||||
| Surgical Technique/Site | ||||
| Preparation | 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 drilling | |||||||
| 56-15904 1.5x4mm self drilling | |||||||
| 56-15905 1.5x5mm self drilling | |||||||
| 56-15004 1,5x4 mm sell tapping | |||||||
| 56-15005 1.5x5mm sell tapping | |||||||
| 56-15006 1.5x6mm sell tapping | |||||||
| 56-17304 1.7x4mm sell tapping emergency | 50-15904 1.5x4mm self drilling | ||||||
| 50-15905 1,5x5mm sed dring | |||||||
| 50-15004 1,5x4mm selt tapping | |||||||
| 50-15005 1.5x5mm selt tapping | |||||||
| 50-15006 1.5x6mm sell tapping | |||||||
| 50-17304 1.7x4 man selt tapping emergency | 04.503.103.01 1.5x3mm self drilling | ||||||
| 04.503.104.01 1,5x4mm self drilling | |||||||
| 04.503.105,01 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 number | |||||||
| K031659 | K022012 | ||||||
| Environment | For Universal Neuro II: Equivalent manufacturer (Stryker Freiburg) on the | ||||||
| equivalent machines using the equivalent machine environment compared | |||||||
| to Universal Neuro II. | |||||||
| Intended Use | n/a | ||||||
| Indications for use | The Stryker® Universal Neuro III implant system as intended for | ||||||
| reconstruction, stabilization and/or rigid fixation of non load-bearing borny | |||||||
| areas subsequent to craniotomy, 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 | |||||||
| foxation of craniofacial fractures and reconstruction in non-load bearing | |||||||
| areas. | The Synthes Matrix 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. | The subject device is intended to be used in cranial areas which are similar | ||||||
| to the predicates, But it is limited to non-load bearing cranial indications | |||||||
| only, whereas the Synthes predicate indications cover facial/orbital or | |||||||
| mandibular sites as well. Additionally the subject is intended to be used in | |||||||
| adolescents 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 Universal | |||
| Neuro II. | |||||||
| For Synthes: Enhanced application area including the one of Universal | |||||||
| Neuro III | |||||||
| Material | Titanium Alloy, Grade V | Titanium Alloy, Grade V | Titanium Alloy | Equivant material, therefore all screws are equal in regard to the | |||
| mechanical 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 II | |||||||
| screws; Verification/Validation testing proved safety of Universal Neuro II | |||||||
| design; | |||||||
| -Core Diameter: Equivalent core diameter for Universal Neuro II and III self | |||||||
| tapping screws and the 5mm self-drilling screws, increased core diameter | |||||||
| for Universal Neuro III 3mm and 4mm self drilling screws increasing the | |||||||
| screw stabilits compared to Universal Neuro II; | |||||||
| -Length: Equivalent to the predicates except for Universal Neuro III 3mm | |||||||
| self 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 Universal | |||||
| Neuro 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
8
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
9
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