← Product Code [GWO](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO) · K121624 # BIOMET MICROFIXATION NEURO PLATING SYSTEM (K121624) _Biomet Microfixation · GWO · Oct 12, 2012 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K121624 ## Device Facts - **Applicant:** Biomet Microfixation - **Product Code:** [GWO](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO.md) - **Decision Date:** Oct 12, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.5320 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## Indications for Use These devices are implantable bone plates and bone screws for neuro procedures including: 1. Fractures 2. Osteotomies 3. Reconstructive procedures 4. Revision procedures where other treatments or devices have failed ## Device Story Biomet Microfixation Neuro Plating System consists of titanium plates and screws for cranial skeletal alignment and stabilization. Plates feature various geometries (straight, angle, mesh, etc.) and screws range from 1.0mm to 2.3mm diameter. Used by surgeons in clinical settings for neurosurgical procedures. Devices are provided non-sterile and require steam sterilization by the user. Implants provide mechanical fixation to support bone healing; failure to follow postoperative instructions or presence of contraindications may lead to complications like nonunion, migration, or infection. ## Clinical Evidence Bench testing only. Testing included validation of cleaning protocols and steam sterilization efficacy per AAMI TIR 12 and ANSI/AAMI/ISO 17665-1:2006. Worst-case sample components demonstrated effective sterilization achieving a 10^-6 Sterility Assurance Level (SAL). ## Technological Characteristics Titanium implantable bone plates and screws. Various geometries including straight, angle, mesh, and matrix. Screw diameters 1.0mm-2.3mm; lengths 3.0mm-6.0mm. Provided non-sterile; steam sterilization required. Mechanical fixation principle. ## Regulatory 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 - Wuerzburg Titanium Mini Bone Plates and Bone Screws ([K854886](/device/K854886.md)) - Lorenz 1.0 MM System ([K922741](/device/K922741.md)) - Lorenz 1.0mm, 1.5mm, 2.0mm Plating system ([K953385](/device/K953385.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Biomet Microfixation. The logo is in black and white and features the word "BIOMET" in large, bold letters on top. Below that, the word "MICROFIXATION" is written in smaller, thinner letters. The logo appears to be for a medical or surgical company. #### 510(k) Summary 510(k) Number: Date Prepared: Submitter: K121624 October 2, 2012 Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218-2480 Contact: #### Sheryl Malmberg, Global Regulatory Affairs Specialist 904-741-4400 fax 904-741-9425 | Common or Usual Name: | Neuro Plating System | | | | Biomet Microfixation
Neuro Plating System | Walter Lorenz
Surgical K854886 | Walter Lorenz
Surgical K922741 | Walter Lorenz
Surgical K953385 | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification Name: | Preformed Alterable
Cranioplasty Plate | Burr Hole Cover | Cranioplasty Plate
Fastener | Material | Titanium | Titanium | Titanium | Titanium | | Device Classification: | II (882.5320) | II (882.5250) | HBW (882.5360) | Indications
for Use | These devices are
implantable bone plates
and bone screws for
cranial procedures
including:
1. Fractures
2. Osteotomies
3. Reconstructive
procedures
4. Revision procedures
where other treatments
or devices have failed. | These devices are
implantable bone
plates and bone
screws for oral,
cranio-maxillofacial
procedures including:
1. Fractures, 2.
Osteotomies,
including
orthognathic
procedures, 3.
Reconstructive
procedures, and 4.
Revision procedures
where other
treatments or devices
have failed. | These devices are
implantable bone
plates and bone
screws for oral,
cranio-maxillofacial
procedures including:
1. Fractures, 2.
Osteotomies,
including
orthognathic
procedures, 3.
Reconstructive
procedures, and 4.
Revision procedures
where other
treatments or devices
have failed. | These devices are
implantable bone
plates and bone
screws for oral,
cranio-maxillofacial
procedures including:
1. Fractures, 2.
Osteotomies,
including
orthognathic
procedures, 3..
Reconstructive
procedures, and 4.
Revision procedures
where other
treatments or devices
have failed. | | Device Product Code: | GWO | GXR | HBW | Use | Single | Single | Single | Single | | Sterility | Provided non-sterile;
steam sterilization
validation on file | Provided non-sterile;
steam sterilization
validation on file | Provided non-sterile;
steam sterilization
validation on file | Provided non-sterile;
steam sterilization
validation on file | | | | | | Shape of
Plates | New shape includes pre-
contoured mesh.
Additional system
plates include variations
of straight, curved,
angle, double angle, L-,
T-, double T-, Z-, X-,
Y-, double Y-shape,
burr hole, triangle,
rectangle, square,
matrix, and mesh
options with various
lengths and thicknesses. | Variations of straight,
curved, L-, T-, Y-
shape, matrix, plate
options. | Variations of straight,
square, rectangular,
and mesh plate
options | Variations of straight,
angle, curved, L-, T-,
double T-, Z-, X-, Y-,
double Y-, H-shape,
triangle, square,
rectangle, matrix,
mesh, orbital floor,
and LeFort plate
options. | | | | | | Screw Sizes | No new screws in this
submission. Additional
system screws range in
diameters of 1.0mm to
2.3 and lengths from
2.0mm to 7.0mm. Head
geometry includes
cross-drive and center
drive, with HT (high
torque) and SD (self-
drilling) options. | Screws range in
diameters of 1.0mm
to 2.3mm and lengths
from 2.0mm to
29.0mm
Head geometry
includes cross-drive
and center drive, with
HT (high torque) and
SD (self-drilling)
options | Not Applicable | Not Applicable | | | | | Device Name: Biomet Microfixation Neuro Plating System #### Intended Use: These devices are implantable bone plates and bone screws for neuro procedures including: - Fractures l . - 2. Osteotomies - 3. Reconstructive procedures - Revision procedures where other treatments or devices have failed 4. #### Contraindications: - Active infection 1. - 2. Foreign body sensitivity. Where material sensitivity is to be completed prior to implantation. - 3. Patients with limited blood supply, insufficient quantity of bone, or latent infection. - 4. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions. Description: Biomet Microfixation manufactures and distributes a variety of internal fixation devices intended to aid in the alignment and stabilization of bone in the cranial skeletal system. Instrumentation has been designed specifically for use with each system of implants. The Biomet Microfixation Cranio/Neuro Plaing System is comprised of a variety of titanium plates and screws with shapes and sizes intended to aid in the alignment and stabilization of bone in the cranial skeletal system. The plates include variations of straight, angle, double angle, L-shape, Z-shape, X-shape, burr hole, triangle, square, matrix, mesh, and crescent options with various lengths and thickness. The screws range in diameters of 1.0mm to 2.3mm and lengths from 3.0mm to 6.0mm. Sterility Information: The plates and screws will be marketed as non-sterile, single use devices. #### Possible risks: - Poor bone formation, Osteolysis, Osteolysis, Osteomyelitis, inhibited revascularization, or infection can 1. cause loosening, bending, cracking or fracture of the device. - 2. Nonunion or delayed union, which may lead to breakage of the implant. - 3. Migration, bending, fracture or loosening of the implant. - Metal sensitivity, or allergic reaction to a foreign body. 4. - న్. Decrease in bone density due to stress shielding. - 6. Pain, discomfort, abnormal sensation, or palpability due to the presence of the device. - 7. Increased fibrous tissue response around the fracture site and/or the implant. - 8. Necrosis of bone. - 9. Inadequate healing. OCT 1 2 2012 {1}------------------------------------------------ 1421624 Substantial Equivalence Biomet Microfixation considers the Neuro Plating System modifications equivalent to the Biomet Microfixation (formally Walter Lorenz Surgical) Wuerzburg Titanium Mini Bone Plates and Bone Screws cleared under K854886, Lorenz 1.0 MM System cleared under K922741, and Lorenz 1.0mm, 1.5mm, 2.0mm Plating system cleared under K953385. Subject pre-contoured mesh are similar to the predicate devices in terms of material, indications, use, sterility, and design. {2}------------------------------------------------ Nonclinical testing: Referenced testing demonstrates that the device can be cleaned and sterilized within the required parameters, demonstrating equivalence to the predicate devices. A worst case scenario of instrumentation was compromised and underwent testing resulting in achieving the required cleaning results as outlined in the testing. The cleaning testing was performed per an FDA approved protocol. Sterility testing, (Reference AAMI TIR 12 and ANSI/AAMI/ISO 17665-1:2006) provided worst case testing by inoculating worst case sample components that then demonstrated results to have been effectively sterilized per required parameters. Conclusion: This testing data supports the determination of substantial equivalence by demonstrating worst case scenarios for both cleaning and sterilization that fall within acceptable parameters providing a 10 * Sterility Assurance Level (SAL). No new safety and efficacy issues were raised. {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 OCT 12 2012 Biomet Microfixation % Ms. Sheryl Malmberg Global Regulatory Affairs Specialist 1520 Tradeport Drive Jacksonville, FL 32218 Re: K121624 Trade/Device Name: Biomet Microfixation Neuro Plating System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed alterable cranioplasty plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: September 11, 2012 Received: September 12, 2012 Dear Ms. Malmberg: 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 {4}------------------------------------------------ ## Page 2 - Ms. Sheryl Malmberg 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 807.97). For questions regarding 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 Image /page/4/Picture/6 description: The image shows a handwritten word, "for", in cursive script. The "f" is elongated with a large loop extending below the baseline, and the "o" and "r" are connected with a smooth, flowing line. The writing appears to be done with a pen or marker, and the overall style is elegant and fluid. 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 · Enclosure {5}------------------------------------------------ # Indications for Use K121624 510(k) Number (if known): Device Name: Biomet Microfixation Neuro Plating System ### Indications For Use: These devices are implantable bone plates and bone screws for neuro procedures including: - 1. Fractures - 2. Osteotomies - 3. Reconstructive procedures - 4. Revision procedures where other treatments or devices have failed AND/OR Prescription Use XX (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ![image](image) (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number K121624 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K121624](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GWO/K121624) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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