Taps are nonpowered hand-held devices intended for bone cutting and drilling on a patient's skull during fracture repair and reconstructive procedures of the cranium. The taps may be used to prepare cranial bone to insert bone fixation screws.

Device Description

Taps are used to drill a hole and simultaneously create threads in order to accommodate a Rapid Resorbable Fixation System bone screw. The self-drilling fixed-stop taps are manufactured from Stainless Steel 440A which conforms to ASTM F899 Standard Specification for Stainless Steel for Surgical Instruments and ASTM A276 Specification for Stainless Steel Bars and Shapes. The adjustable-length taps (final assembly) are assembled from three components; the adjustable tap (Stainless Steel 440A), the locking collar (Makrolon Rx2530 W/1118 Tint), and the stop collar (Stainless Steel 316L with an aluminum titanium nitride coating).

AI/ML Overview

The provided document describes the Synthes Taps for Resorbable Screws (K153587) and the performance testing conducted to support its substantial equivalence to predicate devices. Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Simulated Use/Bioskills Lab - RapidSorb Instruments	Full validation of various aspects of the device design (torque resistance, length, screw size diameter).	The results indicated full validation of the subject device. All acceptance criteria were met.
Saw Bones Lab - RapidSorb Instruments	All four users must be able to use each of the three subject taps to create three separate tapped holes that accommodate the corresponding screw (36 total insertions).	The acceptance criteria was met in that all four users were able to use each of the three subject taps to create three separate tapped holes that will accommodate the corresponding screw (36 total insertions).
Mechanical Test - Torsional Testing of RapidSorb Taps	The failure torque of RapidSorb self-drilling taps must be above the torque at which the same diameter taps will bottom-out in the testing substrate.	P-values of 0.000 for all three sizes (1.5, 2.0, and 2.5 mm) when comparing failure torque to bottoming or stripping torque. This is sufficient evidence to reject the null hypothesis, indicating the RapidSorb failure torque is superior, satisfying the acceptance criteria.
Mechanical Test - RapidSorb Self-Drilling Tap Axial Load at Strip Out	The axial force required to cause the adjustable stop to unintentionally move must be greater than the axial force generated by the strip-out torque of each tap.	P-value of 0.000 for all comparisons (1.5, 2.0, and 2.5mm) for axial load, indicating the axial load required to move the adjustable stop was superior to the axial load at strip-out in all cases, satisfying the acceptance criteria.
Validation of Hex Coupling for RapidSorb Adjustable Taps	All tested parts must couple with the designated hex handles and then be fully inserted into 40 lbs/cf polyurethane foam with no slippage or visible damage (no magnification) of taps proximal coupling.	All participants were able to drive all 12 taps with a combination of the 3 specified handles, with no visible damage to the proximal coupling end of the tap.
Biocompatibility (Cytotoxicity)	No reactivity of causing cell lysis or toxicity. All test method acceptance criteria met.	The test articles extract showed no reactivity of causing cell lysis or toxicity. All test method acceptance criteria were met.

2. Sample Size Used for the Test Set and Data Provenance

Simulated Use/Bioskills Lab:
- Sample Size: 5 individual participants (users) and 4 cadaveric cephaluses (heads).
- Data Provenance: Prospective, from cadaveric cephaluses. Likely from the US, given the submission to the FDA.
Saw Bones Lab:
- Sample Size: 4 users and an unspecified number of "saw bones" (synthetic bone models). The test involved 36 total insertions (implying 3 subject taps x 3 tapped holes x 4 users).
- Data Provenance: Prospective, using synthetic bone models (Sawbones).
Mechanical Tests (Torsional, Axial Load, Hex Coupling Validation):
- Sample Size: For Torsional Testing, all three sizes of RapidSorb Self-Drilling Taps (1.5, 2.0, and 2.5 mm) were tested. For Axial Load, adjustable length taps (311.100, 311.101, 311.102, 311.110, 311.111, 311.112) of 1.5, 2.0, and 2.5mm were compared. For Hex Coupling Validation, 12 taps were driven by "all participants" (number not specified but implied to be multiple, likely the same 5 as the simulated use or similar).
- Data Provenance: In-vitro / bench testing. No specific country of origin or retrospective/prospective distinction is given for the collected data, but it is implied to be newly generated for this submission.
Biocompatibility Testing:
- Sample Size: Not specified for the extract, but presumably standard in-vitro cell culture methods.
- Data Provenance: In-vitro lab testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The concept of "experts" establish ground truth in the traditional sense (e.g., radiologists interpreting images) is not directly applicable here as this is a medical device for surgical procedures (taps).

Simulated Use/Bioskills Lab: "The users are independent from the design of the subject device." No specific qualification (e.g., surgeon, resident) or experience level is mentioned for the 5 participants.
Saw Bones Lab: 4 users. No specific qualifications mentioned.

For mechanical and biocompatibility testing, the "ground truth" is established by the physical and biological properties being measured against established engineering and biological standards.

4. Adjudication Method for the Test Set

No formal adjudication method (like 2+1 or 3+1 consensus) is described for any of the performance tests. The tests appear to involve direct measurement (mechanical tests) or observed outcomes (simulated use, Sawbones lab), with success defined by meeting the specified acceptance criteria. For the "Simulated Use/Bioskills Lab," "The results indicated full validation... All acceptance criteria were met," suggesting a pass/fail outcome rather than a consensus on a specific finding.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a manual surgical instrument, not an AI or imaging diagnostic tool where MRMC studies are typically performed.

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

This question is not applicable. The device is a physical, manual surgical instrument. There is no "algorithm" or AI component to this device.

7. The Type of Ground Truth Used

The "ground truth" primarily relies on:

Performance against engineering specifications: For mechanical tests (torsional, axial load, hex coupling), the ground truth is defined by the device's ability to withstand forces, prevent stripping, and couple correctly according to established engineering benchmarks and statistical comparisons with null hypotheses.
Direct observation of functional performance: For the Simulated Use and Saw Bones labs, the ground truth is observed successful drilling/tapping and accommodation of screws by human users, as per the defined acceptance criteria.
Biological standards: For biocompatibility, the ground truth is the absence of cytotoxicity, evaluated against ISO 10993-5 guidelines.

8. The Sample Size for the Training Set

No training set is mentioned as this device is not an AI/ML algorithm. The performance data presented are for validation/verification testing.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of medical device submission.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.

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

January 18, 2017

Synthes (USA) Products, LLC Ms. Susan Lewandowski Manager, Regulatory Affairs 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K153587

Trade/Device Name: Taps for Resorbable Screws Regulation Number: 21 CFR 882.4300 Regulation Name: Manual Cranial Drills, Burrs, Trephines, and Their Accessories Regulatory Class: Class II Product Code: HBG Dated: December 22, 2016 Received: December 23, 2016

Dear Ms. Lewandowski:

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 devicerelated 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.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Hoffmann -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K153587

Device Name Taps for Resorbable Screws

Indications for Use (Describe)

Taps are nonpowered hand-held devices intended for bone cutting and drilling on a patient's skull during fracture repair and reconstructive procedures of the cranium.

The taps may be used to prepare cranial bone to insert bone fixation screws.

Type of Use (Select one or both, as applicable)

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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the Synthes logo. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, black letters on the right. There is a line underneath the word "SYNTHES".

Date Prepared:	January 18, 2017
Submitter:	Synthes USA Products, LLC1301 Goshen ParkwayWest Chester, PA 19380United States of America
Contact:	Susan Lewandowskislewand2@its.jnj.comTelephone 610-719-5852Facsimile 484-356-9682

DEVICE

Device Name:	Taps for Resorbable Screws
Classification Name:	Drills, burrs, trephines, and accessories (Manual)
Review Panel:	Neurology
Regulatory Class:	II
Product Code:	HBG (Manual cranial drills, burrs, trephines, and their accessories)21 CFR 882.4300

PREDICATE DEVICE

Medtronic Sofamor Danek POWEREASE™ System K123270 is the primary predicate.

Synthes Dental Bone Cutting Instruments K150796 is used as a reference device in support of this submission.

DEVICE DESCRIPTION

DePuy Synthes Taps for Resorbable Screws can be used with the following handles: 311.01.98 Handle, with mini quick coupling 311.03 Handle, with mini quick coupling, small 311.005 Screwdriver Handle with hex coupling, small 311.006 Screwdriver Handle with hex coupling, medium 311.007 Screwdriver Handle with hex coupling, large

The DePuy Synthes Taps for Resorbable Screws can be used with the DePuy Synthes Rapidsorb® Rapid Resorbable Fixation System (K062789) screws [1.5mm, 2.0mm, 2.5mm (Emergency) diameters] and plates (1.5 mm and 2.0mm).

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Synthes. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. The circular symbol appears to be a stylized representation of a medical device or implant. A registered trademark symbol is located to the right of the word "SYNTHES".

INDICATIONS FOR USE

Taps for Resorbable Screws

Medtronic Sofamor Danak POWEREASE System (Primary Predicate)

IPC® System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures. The IPC® POWEREASE™ System is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.

Discussion

Both the subject taps and the primary predicate Medtronic Sofamor Danek POWEREASE System K123270 are intended for use in neurosurgical procedures to drill or cut into the skull. There is a difference in the assigned FDA product codes:

The subject taps are manual instruments, with a corresponding product code of . HBG (Drills, burrs, trephines, and their accessories - manual).
The primary predicate is a powered instrument with the corresponding product code of HBE (drills, burrs, trephines, and accessories - simple, powered).

Additionally, the subject taps defined herein as Class II product code HBG are the same instruments currently marketed by Synthes as Class I product code LXH (Orthopedic manual surgical instruments). Thus, the subject taps include the intended uses of both product codes (i.e. cranial bone-cutting and general orthopedic bone cutting).

The reference device Synthes Dental Bone Cutting Instruments K150796 does not have the same intended use as the subject taps since the dental bone cutting instruments are intended for trauma, reconstruction, or orthognathic procedures to drill or cut into the upper or lower jaw. The reference device product code is DZJ (Driver, wire, and Bone Drill Manual). Since taps for general orthopedic bone-cutting would typically be considered Class I Exempt instruments, the identified reference device is included to show that taps have been previously cleared within premarket notification submissions.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Primary Predicate

DePuy Synthes considers the subject taps equivalent to the Medtronic Sofamor Danek Sofamor Danek POWEREASE™ System K123270, as well as the Synthes Dental Bone Cutting Instruments K150796.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A small "R" in a circle is located to the right of the word "SYNTHES", indicating that it is a registered trademark.

Technological Similarities of Taps to the Primary Predicate

Both instruments are used for drilling a hole in preparation for a bone screw ●
. Both are used in the skull
Both can be used manually
The Medtronic POWEREASE™ System consists of a hand piece and ● attachments; the subject taps consist of the instruments and handles based on the coupling

Technological Differences of Taps to Primary Predicate

The Medtronic POWEREASE™ System is used for drilling, tapping and driving . screws as well as for the placement or cutting of screws, posts and rods; the tap is used to drill a hole and simultaneously create threads in order to receive a bone screw
The Medtronic POWEREASE™ System can be used manually or with power; the ● subject taps are manual instruments only
The Medtronic IPC® and POWEREASE™ Systems (K123270) are used in ● Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures; the subject taps are intended for neurosurgical procedures only

Impact on Safety and Effectiveness

There is no impact to safety and effectiveness. The subject devices have a limited intended use compared to the predicate device; the POWEREASE System is used for drilling, tapping, and driving screws while the taps are used to cut bone in preparation of receiving a bone screw. The subject devices are basic handheld instruments compared to the predicate; the tap is connected to a handle (dependent on the coupling feature) while the predicate device consists of a handpiece and multiple attachments. The subject devices are used manually while the predicate can be used either manually or with power.

Reference Device

Both the subject taps and the reference Dental Bone Cutting Instruments (K150796) are generally intended to be used during surgery for cutting into bone. The reference device is included to show that taps have been cleared within premarket submissions.

Technological Similarities of Taps to the Reference Device

Both devices are intended to be used to prepare bone for placement of a screw
Both devices are operated manually ●
Both are manufactured from stainless steel (440A) .

Technological Differences of Taps to the Reference Device

The subject taps are intended for use in fracture repair and reconstructive procedures of the cranium (covered under a Neurology product code); the Dental Bone Cutting Instruments are intended for use in oral/maxillofacial surgery (covered under a Dental product code).

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the Synthes logo. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. A registered trademark symbol is located to the upper right of the word "SYNTHES". A horizontal line is located underneath the logo.

Impact on Safety and Effectiveness

There is no impact to safety and effectiveness. The subject taps are intended for use in fracture repair and reconstructive procedures of the cranium (Neurology); the Dental Bone Cutting Instruments are intended for use in oral/maxillofacial surgery (Dental). Regardless of specific intended use, all taps are used to cut bone in preparation of receiving a bone screw. The reference device was included to provide evidence that taps have been cleared within premarket notification submissions.

PERFORMANCE DATA

Mechanical Testing

The performance data provided in support of substantial equivalence of the proposed devices are as follows:

Simulated Use/Bioskills Lab ●
Sawbones Lab ●
Torsional Testing of RapidSorb Taps
. RapidSorb Self-Drilling Tap Axial Load at Strip Out
Validation of Hex Coupling for RapidSorb Adjustable Taps ●
Biocompatibility Testing - Cytotoxicity

Performance Testing - Bench
Test	Test Method Summary	Results
Simulated Use/Bioskills Lab -RapidSorb Instruments	A representative range of thesubject devices will be selected torepresent the entire range of taps.The lab will be conducted tovalidate various aspects of thedevice design such as torqueresistance, length and screw sizediameter. The validation lab willconsist of 5 individualparticipants. There will be 4cadaveric cephalises. The heads(cephalises) will be selected torepresent a range of patients (ayoung male and female, andelderly male and female). Theusers are independent from thedesign of the subject device.	The results indicated fullvalidation of the subject device.All acceptance criteria were met.
Saw Bones Lab - RapidSorbInstruments	The objective of the lab is tovalidate that the subject taps areable to self-drill in normal densitybone. A representative range ofthe subject device will be selectedto represent the entire range oftaps. The range includes alldiameters and the longest lengthof each tap. These representworst case in regard to torqueresistance.	The acceptance criteria was metin that all four users were able touse each of the three subject tapsto create three separate tappedholes that will accommodate thecorresponding screw (36 totalinsertions).

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Synthes. The logo consists of a stylized symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. A registered trademark symbol is located to the right of the word "SYNTHES". A horizontal line is located underneath the logo.

Performance Testing - Bench
Test	Test Method Summary	Results
Mechanical Test - TorsionalTesting of RapidSorb Taps	The objective of this test is todemonstrate that the failuretorque of RapidSorb self-drillingtaps is above the torque at whichthe same diameter taps willbottom-out in the testingsubstrate. Two separate tests willbe performed, Failure TorqueTest and Stripping Torque Test.	The results of this testing indicatethat when the failure torque of allthree sizes of RapidSorb SelfDrilling Taps (1.5, 2.0, and 2.5mm) are compared to theirrespective bottoming or strippingtorque, the resulting p-valueswere all 0.000. There issufficient evidence to reject thenull hypothesis in favor of thealternate, that in all cases theRapidSorb failure torque issuperior to the Bottoming orStripping torque (as specified).This satisfies the acceptancecriteria.
Mechanical Test - RapidSorbSelf-Drilling Tap Axial Load atStrip Out	The objective of this test was todemonstrate that the axial forcerequired to cause the adjustablestop on the adjustable length taps(311.100, 311.101, 311.102,311.110, 311.111, 311.112) tounintentionally move is greaterthan the axial force that isgenerated by the strip out torqueof each tap.	As can be seen in all comparisons(1.5, 2.0, and 2.5mm) theresulting p-value was 0.000,which is sufficient evidence toreject the null hypothesis in favorof the alternate that the Axialload required to move theadjustable stop was superior tothe axial load at strip-out in allcases. This result satisfies theacceptance criteria.
Validation of Hex Coupling forRapidSorb Adjustable Taps	The objective of this test was tovalidate the compatibility of theHex coupling on the proximal endof the RapidSorb Adjustablelength taps. All tested parts willcouple with the designated hexhandles and, then be fully insertedinto 40 lbs/cf polyurethane foamwith no slippage or visibledamage (no magnification) oftaps proximal coupling.	At the conclusion of the testing,all participants were able to driveall 12 taps with a combination ofthe 3 specified handles. This wasdone with no visible damage tothe proximal coupling end of thetap.
Biocompatibility (Cytotoxicity)	An in vitro study was conductedto evaluate for potential cytotoxiceffects, following guidelines ofthe ANSI/AAMI/ISO 10993-5,Biological Evaluation of medicaldevices – Part 5: Test for in vitrocytotoxicity (2009).	At the conclusion of the testing,the test articles extract showed noreactivity of causing cell lysis ortoxicity. All test methodacceptance criteria were met.The patient contactingcomponents of taps aremanufactured from StainlessSteel 440A which conforms tothe FDA recognized consensusstandard, ASTM F899 - StandardSpecification for Stainless Steelfor Surgical Instruments,supporting the biocompatibilityof this device.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A registered trademark symbol is located to the right of the word.

Performance testing demonstrates that the mechanical performance of the proposed taps is comparable to that of the primary predicate device (taps) and supports substantial equivalence.

Clinical Studies

Clinical testing was not necessary for the determination of substantial equivalence.

The performance data demonstrate that the mechanical performance of the proposed taps is comparable to that of the primary predicate device and supports substantial equivalence to the primary predicate device for safe and effective bone cutting in the skull.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for SYNTHES. The logo consists of a stylized symbol on the left, followed by the word "SYNTHES" in bold, sans-serif font. A registered trademark symbol is located to the right of the word. The logo is black and white.

CONCLUSIONS

The proposed devices have the same intended use as the primary predicate device. The mechanical testing included in this submission demonstrates that:

Any differences in technological characteristics of the primary predicate and/or . reference device do not raise any new questions of safety and effectiveness.
. The proposed devices are at least as safe and effective as the primary predicate

It is concluded that the information included in this submission supports substantial equivalence.

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized figure inside. A registered trademark symbol is located to the right of the word.

Device Comparison Table

	DePuy Synthes Taps forResorbable Screws (subjectdevice)	Medtronic Sofamor DanekPOWEREASE SystemK123270(primary predicate)	DePuy Synthes Dental BoneCutting Instruments, e.g. Tapsand Countersinks K150796(reference device)
Indications for use	Taps are nonpowered hand-helddevices intended for bonecutting and drilling on a patient'sskull during fracture repair andreconstructive procedures of thecranium. The taps may be usedto prepare cranial bone to insertbone fixation screws.	The IPC System is indicated forthe incision/cutting, removal,drilling and sawing of soft andhard tissue and bone, andbiomaterials in Neurosurgical(Cranial, Craniofacial),Orthopedic, Arthroscopic,Spinal, Sternotomy, and Generalsurgical procedures.The IPC POWEREASE Systemis indicated for drilling, tappingand driving screws and workingend attachments during spinalsurgery, including open andminimally invasive procedures.It is also used in the placementor cutting of screws, posts androds.	The Dental Bone CuttingInstruments are nonpoweredhand-held devices intended fortrauma, reconstruction, ororthognathic procedures to drillor cut into the upper or lowerjaw and may be used to preparebone to insert a wire, pin, orscrew.
FDA Product Code	HBG	HBE, HWE, GWF	DZJ
21 CFR	882.4300	882.4310	872.4120
RegulationDescription	Manual cranial drills, burrs,trephines, and their accessories	Powered simple cranial drills,burrs, trephines, and theiraccessories	Bone cutting instrument andaccessories
Review Panel	Neurology	Neurology	Dental
Device Class	2	2	2
Device Description	Taps are used to drill a hole andsimultaneously create threads inorder to accommodate a RapidResorbable Fixation Systembone screw. The taps areavailable as self-drilling fixed-stop taps and self-drillingadjustable-stop taps.	The POWEREASETM SystemWorking Ends consists ofinstruments such as taps, drillbits, screwdrivers, post cutter,set screw break-off tool,reduction nut driver and sleeves.The working ends have a manualalternative. The working ends,listed above, are compatible withthe CD HORIZON SOLERAand the TSRH 3Dx SpinalSystem implants. Of the workingends, only the taps, screwdrivers,drill bits, and sleeves are alsocompatible with Medtronic'sNIM-ECLIPSE Spinal System.	Countersinks are intended tocreate a countersink feature inbone to provide a contact surfacefor screw heads and to reducepalpability of the bone screw.Taps are intended to createthreads in a pre-drilled hole inorder to accomodate a bonescrew.
Technologicalcharacteristics:
Principles offunction/technology	Taps are designed to becompatible with correspondingSynthes screws and/or drill bits.Taps have cutting threads thatrun along the length of theinstrument. The diameter and	The instrument modificationsdetailed in this submission haveno impact on the technologicalcharacteristic of the existinginstruments. The working endTaps are intended for tapping	Countersinks feature cuttingflutes at the working end of theinstrument that continue adistance up the shaft of theinstrument and a centering pin atthe working end of the
	DePuy Synthes Taps forResorbable Screws (subjectdevice)	Medtronic Sofamor DanekPOWEREASE SystemK123270(primary predicate)	DePuy Synthes Dental BoneCutting Instruments, e.g. Tapsand Countersinks K150796(reference device)
	thread profile of the tap isdesigned to match to thediameter and thread profile of anassociated screw.	during spinal surgery, includingboth open and minimallyinvasive procedures. Theworking ends are used tofacilitate the placement of therods. Like the predicatePOWEREASE Systeminstruments, the subjectinstruments are manufacturedfrom stainless steel.	instrument. The user will insertthe centering pin into a drilledpilot hole, ensuring that thecountersink feature is concentricwith the drilled hole.Taps are designed to becompatible with correspondingSynthes screws and/or drill bits.Taps have cutting threads thatrun along the length of theinstrument. The diameter andthread profile of the tap isdesigned to match to thediameter and thread profile of anassociated screw.
Dimensions
Stop Depth:	Fixed stop taps: 3mm, 4mm,5mm, 6mm, 8mmAdjustable stop taps: 3-8mm(1mm increments)	Unknown	20-122mm tapping depths
Couplings:	Mini-quick couplingHex coupling	Unknown	Hex coupling
CompatibleScrews:	Rapidsorb resorbable cortexscrews: 1.5mm, 2.0mm, 2.5mmdiameter	Unknown	Cortex screws: 1.3-3.0mmdiameter
Device material(s)	Stainless steel 440A, 316LPolycarbonate (MakrolonRx2530 W/1118 Tint)Aluminum titanium nitridecoating	Stainless Steel	Stainless steel 440A

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the Synthes logo. The logo consists of a circular icon on the left and the word "SYNTHES" in bold, black letters on the right. The icon features a stylized image of a person or figure within a circle, and a registered trademark symbol is located at the upper right of the word "SYNTHES".

(End of summary)

Regulation Number and Section

§ 882.4300 Manual cranial drills, burrs, trephines, and their accessories

(a)
Identification. Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.(b)
Classification. Class II (performance standards).