DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)

Q: Who is the manufacturer of DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)?

Pro Med Instruments GmbH filed the 510(k) submission for DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) (K193438).

Q: What is the FDA product code for DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)?

HBL. It is classified under 21 CFR 882.4460 as a Class 2 device in the Neurology panel.

Q: What is the regulatory pathway for DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)?

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

Q: What are the predicate devices for DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)?

TZ Skull Pin Adult (K163322); Mayfield Child Disposable Skull Pin (K941558); Limited Artifact Skull Pin (K073163).

Q: Who can help prepare an FDA 510(k) submission like DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)?

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.

K193438 · Pro Med Instruments GmbH · HBL · Jun 2, 2020 · Neurology

Device Facts

Record ID	K193438
Device Name	DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
Applicant	Pro Med Instruments GmbH
Product Code	HBL · Neurology
Decision Date	Jun 2, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4460
Device Class	Class 2
Attributes	Pediatric

Intended Use

The DORO® Sterile Disposable Skull Pin is utilized in a skull clamp and is applied to the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The skull clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.

Device Story

Disposable skull pins for use with skull clamps to provide rigid head and neck fixation during neurosurgical and spinal procedures. Available in stainless steel (MR unsafe) and titanium (MR conditional) versions for adult and pediatric patients. Pins are inserted into the rocker arm and opposite side of a skull clamp. Titanium version allows for intra-operative X-ray, CT, or MR imaging. Device is supplied sterile via gamma irradiation for single-patient use. Healthcare providers (surgeons) install pins into headrest systems to stabilize the patient's head, facilitating surgical access and precision.

Clinical Evidence

Bench testing only. Testing included axial load and creep tests, shear tests, transport validation, packing integrity, system handling, biocompatibility (cytotoxicity and chemical analysis), color coding verification, sterility testing (VDmax and dye penetration), and MR compatibility for titanium models. All tests passed.

Technological Characteristics

Materials: Stainless Steel 1.4034 or Titanium Grade 5 (Ti-6Al-4V) with PA6 polymer base. Sensing/Actuation: Mechanical fixation via skull clamp. Energy: None. Form factor: Adult/Pediatric pins. Connectivity: None. Sterilization: Gamma irradiation. Software: None.

Indications for Use

Indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. Not intended for use on infants or children under 5 years of age.

Regulatory Classification

Identification

A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.

Predicate Devices

TZ Skull Pin Adult (K163322)
Mayfield Child Disposable Skull Pin (K941558)
Limited Artifact Skull Pin (K073163)

Related Devices

K241883 — DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50) · Pro Med Instruments GmbH · Jul 26, 2024
K072208 — MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS · Integra LifeSciences Corporation · Sep 7, 2007
K071458 — MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS · Integra LifeSciences Corporation · Jun 13, 2007
K053045 — MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 · Integra LifeSciences Corporation · Nov 21, 2005
K021604 — MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 · Ohio Medical Instrument Co., Inc. · Jul 29, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 2, 2020 Pro Med Instruments GmbH Muhammad Zubair Regulatory Affairs Manager Boetzinger Str. 38 Freiburg, 79111 De ### Re: K193438 Trade/Device Name: DORO Sterile Disposable Skull Pins (Stainless Steel), DORO Sterile Disposable Skull Pins (Titanium) Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical Head Holder (Skull Clamp) Regulatory Class: Class II Product Code: HBL Dated: April 29, 2020 Received: May 4, 2020 ### Dear Muhammad Zubair: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Adam D. Pierce. Ph.D. Acting Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K193438 Device Name DORO Sterile Disposable Skull Pins (Stainless steel & Titanium) Indications for Use (Describe) Indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### DATE: June 2, 2020 ## DOCUMENT NUMBER: K193438 APPLICANT: Pro Med Instruments GmbH Bötzinger Straße 38 79111 Freiburg im Breisgau Germany Tel: + 49 (0) 761 384 222 10 Fax: +49 (0) 761 384 222 81 E-Mail: pmi@pmisurgical.com ## CONTACT PERSON: Name: Muhammad Zubair Position: Regulatory Affairs Manager Tel.: +49 761 384 222 67 E-Mail: ra@pmisurgical.com {4}------------------------------------------------ #### 1. Device Name | Trade Name: | DORO® Sterile Disposable Skull Pins | |-----------------------------|-------------------------------------------| | Common Name: | Skull Pins | | Device Classification Name: | Holder, head, neurosurgical (skull clamp) | #### 2. Classification / Product Code DORO® Sterile Disposable Skull Pins can be classified according to following device name and product code: | Device | Regulation Description | Regulation Medical Specialty | Review Panel | Product Code | Regulation Number | Device Classification | |-------------------------------------------------|-----------------------------------------------|------------------------------------|-----------------|-----------------|----------------------|--------------------------| | Holder, head, neurosurgical (skull clamp) | Neurosurgical head holder (skull clamp) | Neurology | Neurology | HBL | 882.4460 | 2 | #### Predicate Device 3. ### Subject Device 1: DORO® Sterile Disposable Skull Pins (Stainless Steel) | Subject Device | Predicate Device | 510(k) Number | 510(k) Holder | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|---------------|--------------------------------------| | DORO® Sterile Disposable Skull Pins (Stainless Steel) Model: 1. (3006-00 Stainless Steel, Adult, Blue) 2. (3006-50 Stainless Steel, Adult, Black) | TZ Skull Pin Adult | K163322 | TZ Medical, Inc. | | 3. (3006-10 Stainless Steel, Pediatric, Yellow) | Mayfield Child Disposable Skull Pin | K941558 | OHIO MEDICAL INSTRUMENT CO., INC. | {5}------------------------------------------------ | Device | Predicate Device | 510(k) Number | 510(k) Holder | |-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------|-------------------------------------------------------------------------| | DORO® Sterile Disposable Skull Pins (Titanium) Model: 1. (3006-20 Titanium, Adult, Orange) 2. (3006-30 Titanium, Pediatric, Green) | Limited Artifact Skull Pin Mayfield Child Disposable Skull Pin | K073163 K941558 | Dinkier Surgical Devices, Inc. OHIO MEDICAL INSTRUMENT CO., INC. | ### Subject Device 2: DORO® Sterile Disposable Skull Pins (Titanium) #### 4. Device Description DORO® Sterile Disposable Skull Pins are a disposable device. These are delivered sterile (gamma-sterilization), ready for use, and are intended to be disposed after one use. DORO® Sterile Disposable Skull Pins are available in 2 different types (Stainless steel & Titanium) and 2 different sizes (Adult & Pediatric). #### DORO® Sterile Disposable Skull Pins (Stainless Steel) 4.1. DORO® Sterile Disposable Skull Pins are used together with the DORO ® Headrest Systems, intended as a neck and head support to stabilize the patient's head during neurosurgical procedures. Two DORO® Sterile Disposable Skull Pins are inserted into the rocker arm side of the skull clamp and one single skull pin is inserted in the opposite side. #### DORO® Sterile Disposable Skull Pins (Titanium) 4.2. DORO® Sterile Disposable Skull Pins are used together with the DORO ® Headrest System, intended as a neck and head support to stabilize the patient's head during neurosurgical procedures. Two DORO® Sterile Disposable Skull Pins are inserted into the rocker arm side of the skull clamp and one skull pin is inserted in the opposite side. DORO® Sterile Disposable Skull Pins (Titanium) are used when Intra-Operative X-Ray-, CTor MR Imaging of the patient is used. {6}------------------------------------------------ ## 5. Indications for Use The DORO® Sterile Disposable Skull Pin is indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. #### Technological Characteristics 6. The technological characteristics of DORO® Sterile Disposable Skull Pins are the same as the technological characteristics of the predicate device. ## 6.1. DORO® Sterile Disposable Skull Pins (Stainless Steel) | Company | pro med instruments GmbH (New Device) | TZ Medical, Inc. (Predicate Device) | | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | DORO® Sterile Disposable Skull Pins (Stainless steel) | TZ Skull Pin Adult | | | Regulation Number | 882.4460 | 882.4460 | | | Class | 2 | 2 | | | Code | HBL | HBL | | | 510(k) number | K193438 | K163322 | | | Intended Use | The DORO® Sterile Disposable Skull Pin is utilized in a skull clamp and is applied to the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The skull clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. | The TZ Medical skull pin is placed in a clamp and is applied to the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. | | | Indication for Use | Indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. | Indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. | | | Material | Stainless Steel 1.4034 with a polymer base PA6 | 316L (1.4404 ) Stainless Steel | | | Size | Adult | Adult | | | Dimension | | | | | Tip to Shoulder Distance | Adult: 0.5 Inches | Adult: 0.5 Inches | | | Width of back | Adult: 0.31 inches | Adult:0.31 inches | | | O-ring | 3006-00 Stainless Steel, Adult, Blue 3006-50 Stainless Steel, Adult, Black | No O-Ring Nitrile butadiene rubber (NBR) O- Ring Silicone O-Ring | | | | pro med instruments GmbH (New Device) | | TZ Medical, Inc. (Predicate Device) | | Company | | | | | Manufacturing | 3006-00 Stainless Steel, Adult, Blue 3006-50 Stainless Steel, Adult, Black | The pin insert is machined according to the dimensions specified, and cleaned afterwards. The Pin collet is injection- molded around the Pin insert in controlled environmental conditions. The pin is machined according to the dimensions specified, and cleaned afterwards. Assembly of the O-ring takes place in controlled environmental conditions. | The pin is machined to the dimensions specified. O-Ring is placed on device when manufacturing and cleaning is completed. | | Preparation for surgery | None, the pins are supplied sterile in a 3-pack pouch ready for use | | None, the pins are supplied sterile in a 3- pack pouch ready for use | | Method of Use | Typically , three pins are installed in receptacles of the head holder | | Typically, three pins are installed in receptacles of the head holder | | Clamp Compatibility | DORO® Sterile Disposable Skull Pins are compatible with all the models of Doro brand skull clamps | | V. Mueller Spetzler Skull Clamp-Model # M-1500 Integra Mayfield Skull Clamp- Model # A- 1059 Integra Mayfield Skull Clamp- Model # A- 2000 | | MR Compatibility | MR Unsafe | | MR Unsafe | | Method of Sterilization | Gamma Irradiation | | Ethylene Oxide | | Use | Disposable; Single-Patient Use only | | Disposable; Single-Patient Use only | | Packaging | Medical grade packaging (sealed TYVEK/Blister) | | Medical grade packaging (sealed TYVEK (flexible film pouches) | | Company | pro med instruments GmbH (New Device) | OHIO MEDICAL INSTRUMENT CO., INC. (Predicate Device) | | | Device Name | DORO® Sterile Disposable Skull Pins (Stainless steel) | Mayfield Child Disposable Skull Pin | | | Regulation Number | 882.4460 | 882.4460 | | | Class | 2 | 2 | | | Code | HBL | HBL | | | 510(k) number | K193438 | K941558 | | | Intended Use | The DORO® Sterile Disposable Skull Pin is utilized in a skull clamp and is applied to the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The skull clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. | Information not publically available in 510 (k) summary | | | Indication for Use | Indicated for use in combination with a skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. | Information not publically available in 510 (k) summary | | | Recommended Age of use | The disposable skull pin is not intended for use on infants or children under 5 years of age. | The disposable skull pin is not intended for use on infants or children under 5 years of age. | | | Material | Stainless Steel 1.4034 with a polymer base PA6 | Information not publically available in 510 (k) summary | | | Size | Pediatric | Pediatric | | | Dimension | | | | | Tip to Shoulder Distance | Pediatric: 0.4 Inches | Information not publically available in 510 (k) summary | | | Width of back | Pediatric: 0.31 inches | Information not publically available in 510 (k) summary | | | O-ring | 3006-10 Stainless Steel, Pediatric, Yellow | Information not publically available in 510 (k) summary | | ### Adult: {7}------------------------------------------------ {8}------------------------------------------------ ## Pediatric: {9}------------------------------------------------ | Company | pro med instruments GmbH (New Device) | OHIO MEDICAL INSTRUMENT CO., INC. (Predicate Device) | | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------| | Manufacturing | 3006-10 Stainless Steel, Pediatric, Yellow The pin insert is machined according to the dimensions specified, and cleaned afterwards. The Pin collet is injection- molded around the Pin insert in controlled environmental conditions. | Information not publically available in 510 (k) summary | | | Preparation for surgery | None, the pins are supplied sterile in a 3-pack pouch ready for use | Information not publically available in 510 (k) summary | | | Method of Use | Typically, three pins are installed in receptacles of the head holder | Information not publically available in 510 (k) summary | | | Clamp Compatibility | DORO® Sterile Disposable Skull Pins are compatible with all the models of Doro brand skull clamps | Information not publically available in 510 (k) summary | | | MR Compatibility | MR Unsafe | Information not publically available in 510 (k) summary | | | Method of Sterilization | Gamma Irradiation | Information not publically available in 510 (k) summary | | | Use | Disposable; Single-Patient Use only | Information not publically available in 510 (k) summary | | | Packaging | Medical grade packaging (sealed TYVEK/Blister) | Information not publically available in 510 (k) summary | | | Company | pro med instruments GmbH (New Device) | Dinkier Surgical Devices, Inc. (Predicate Device) | | | Device Name | DORO® Sterile Disposable Skull Pins (Titanium) | Limited Artifact Skull Pin | | | Regulation Number | 882.4460 | 882.4460 | | | Class | 2 | 2 | | | Code | HBL | HBL | | | 510(k) number | K193438 | K073163 | | | Intended Use | The DORO® Sterile Disposable Skull Pin is utilized in a skull clamp and is applied to the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The skull clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. | Limited Artifact Skull Pins are used with a head holder device that is placed on the patients'skull to hold their head and neck in a particular position during surgical procedures when rigid skeletal fixation is desired. | | | Indication for Use | Indicated for use in combination with skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. | Indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and during intra- operative use within a MR environment rated up to and including a 1.5 Tesla magnetic Field | | | Material | Titanium Grade 5 (Ti-6Al-4V) with a polymer base PA6 | The pin tip is Titanium 6Al-4V and the polymer base is PEEK with 10% carbon filler | | | Dimension | | | | | Tip to Shoulder Distance | Adult: 0.5 Inches | Information not publically available in 510 (k) summary | | | Width of back | Adult: 0.31 inches | Information not publically available in 510 (k) summary | | | O-ring | 3006-20 Titanium, Adult, Orange) No O-Ring | O-Ring | | | Manufacturing | The pin insert is machined according to the dimensions specified, and cleaned afterwards. The Pin collet is injection- molded around the Pin insert in controlled environmental conditions. | The pin tip is machined to the dimensions listed on the pin tip drawing. The pin tip is injection molded to the dimensions listed on the pin base drawing. | | | Preparation for surgery | None, the pins are supplied sterile in a 3-pack pouch ready for use. | None, the pin are supplied sterile in a 3-pack pouch ready for use. | | | Method of Use | Typically , three pins are installed in | Typically , three pins are installed in | | | Company | pro med instruments GmbH (New Device) | Dinkier Surgical Devices, Inc. (Predicate Device) | | | Clamp Compatibility | DORO® Sterile Disposable Skull Pins are compatible with all the models of Doro brand skull clamps | Information not publically available in 510 (k) summary | | | MR Compatibility | MR Conditional Main magnetic field strength: 1.5 Tesla or 3 Tesla | MR Conditional | | | Method of Sterilization | Gamma Irradiation | radiation sterilized | | | Use | Disposable; Single-Patient Use only | | | | Packaging | Medical grade packaging (sealed TYVEK/Blister) | Medical grade packaging (sealed TYVEK/flexible film pouches) | | | Company | pro med instruments GmbH (New Device) | OHIO MEDICAL INSTRUMENT CO., INC. (Predicate Device) | | | Device Name | DORO® Sterile Disposable Skull Pins (Titanium) | Mayfield Child Disposable Skull Pin | | | Regulation Number | 882.4460 | | | | Class | 2 | 2 | | | Code | HBL | HBL | | | 510(k) number | K193438 | K941558 | | | Intended Use | The DORO® Sterile Disposable Skull Pin is utilized in a skull clamp and is applied to the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The skull clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. | Information not publically available in 510 (k) summary | | | Indication for Use | Indicated for use in combination with skull clamp in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. | Information not publically available in 510 (k) summary | | | Recommended Age of Use | The disposable skull pin is not intended for use on infants or children under 5 years of age. | The disposable skull pin is not intended for use on infants or children under 5 years of age. | | | Material | Titanium Grade 5 (Ti-6AI-4V) with a polymer base PA6 | Information not publically available in 510 (k) summary | | | Size | Pediatric…