For Lateral Patient Registration:
The Navbit® Sprint System is a computer-controlled system intended to assist the surgeon in relation to reference axes during orthopedic surgical procedures. The Navbit® Sprint System facilitates the accurate positioning of implants, relative to these alignment axes.
The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a lateral decubitus position.
The Navbit® Sprint System for lateral patient registration is indicated for use:

. in Hip Arthroplasty surgical procedures;
with acetabular cups that are uncemented and allow for post-impaction correction; .
when post-impaction confirmatory measurement checks can be obtained.

For Supine Patient Registration:
The Navbit® Sprint System is a computer-controlled system intended to assist the surgeon in relation to reference axes during orthopedic surgical procedures. The Navbit® Sprint System facilitates the accurate positioning of implants, relative to these alignment axes.
The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a supine position.
The Navbit® Sprint System for supine patient registration is indicated for use:

in Hip Arthroplasty surgical procedures; .
with acetabular cups that are uncemented and allow for post-impaction correction; .
. when post-impaction confirmatory measurement checks can be obtained.

Device Description

The Navbit® Sprint System is a computer assisted surgical navigation system for use in hip arthroplasty procedures. The Navbit® Sprint System utilizes a palm-sized computer module containing sensors including rate gyroscopes and accelerometers to generate real time angular measurements (inclination and anteversion angles) used to guide acetabular cup implantation during orthopedic procedures.
During hip arthroplasty procedures, the Navbit® Sprint System assists the surgeon in registering the pelvic coordinate system and determining the inclination angle and the anteversion angle of the introducer/impactor relative to the registered pelvic coordinate system.
The device requires registration to be performed in one of two acceptable patient positions - supine and lateral, and alignment guidelines are provided for each. Any surgical approach that allows this registration to be performed is appropriate for use with the Navbit® Sprint.
The Navbit® Sprint System is provided terminally sterilized, single-use disposable.

AI/ML Overview

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text.

It's important to note that the provided text is a 510(k) summary, which is a high-level overview. It does not contain detailed results, specific performance metrics for acceptance criteria, or most of the information requested regarding study design (sample size, expert qualifications, etc.). The document states that "All tests confirmed the product met the predetermined acceptance criteria," but it does not list what those criteria are or the exact performance achieved against them.

Therefore, I will extract what is available and highlight where information is missing.

Acceptance Criteria and Device Performance (Partial)

The document primarily relies on non-clinical testing, particularly "System accuracy testing: bench testing with mechanical fixtures to verify angular measurement accuracy using ASTM F2554-18" and "Simulated use (cadaver) testing…to validate that the system meets the requirements for user needs in a simulated use environment provides validation evidence that the product met the predetermined clinical pass/fail criteria."

While specific numerical acceptance criteria and reported device performance are not explicitly detailed in a table, the document states:

"All tests confirmed the product met the predetermined acceptance criteria."
"Performance testing addressed the functionality and surgical procedure workflows/steps as defined in the Navbit® Sprint user manual and demonstrates that the Navbit® Sprint System is as safe, as effective, and performs as well as the predicate device [OrthAlign Plus® System (K172462)]."

Based on the mention of ASTM F2554-18, the acceptance criteria would likely be related to accuracy for positional measurements. Without the actual criteria and results, a complete table cannot be generated.

Inferred Acceptance Criteria (Based on ASTM F2554-18):

Acceptance Criteria Category	Inferred Specifics (if known, based on ASTM F2554-18)	Reported Device Performance (as stated in document, actual values not provided)
System Accuracy (Angular Measurement)	Likely thresholds for angular deviation (e.g., within X degrees for inclination and anteversion).	"All tests confirmed the product met the predetermined acceptance criteria." and "demonstrates that the Navbit® Sprint System is as safe, as effective, and performs as well as the predicate device."
Functionality	Device performs as described in the user manual for hip arthroplasty procedures.	"Performance testing addressed the functionality and surgical procedure workflows/steps as defined in the Navbit® Sprint user manual."
Simulated Use (Clinical Pass/Fail Criteria)	User needs met in a simulated surgical environment (e.g., successful registration, accurate guidance).	"product met the predetermined clinical pass/fail criteria."

Study Details:

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size:
  - Bench Testing (ASTM F2554-18): Not specified. Likely involved a series of repeatable measurements on mechanical fixtures.
  - Simulated Use (Cadaver) Testing: Not specified. The number of cadavers used is not mentioned.
- Data Provenance: The studies appear to be prospective bench and cadaver tests conducted by Navbit Pty Ltd or its partners. The country of origin of the data is not specified, but the company is based in Australia.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Bench Testing: Ground truth for angular accuracy in bench testing is typically established by the precision of the mechanical fixtures and reference measurements (e.g., using a goniometer or inclinometer, or highly accurate instrumentation).
- Simulated Use (Cadaver) Testing: The document mentions "an advising surgeon," implying at least one surgeon. Their specific qualifications (e.g., years of experience, subspecialty) are not specified. The nature of how "ground truth" was established in the cadaveric setting is also not detailed (e.g., post-implantation CT scan, radiographic measurement, etc.).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. Given the nature of bench testing (quantitative measurements against a standard) and cadaver testing with an "advising surgeon," a formal multi-reader adjudication process (like 2+1 or 3+1) is unlikely to have been performed in the context of this device's validation.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study was not performed, nor was it required for this 510(k) submission. The device is a navigation system, not an AI for image interpretation that typically necessitates MRMC studies. The human "readers" would be surgeons, and the device assists them, rather than an AI interpreting images for human readers.
- Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this was not an AI-assisted diagnostic/interpretive device in the traditional sense, and no such comparative study was conducted or reported.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, partially. The "System accuracy testing: bench testing with mechanical fixtures to verify angular measurement accuracy using ASTM F2554-18" can be considered a standalone performance assessment of the device's measurement capabilities. This evaluates the algorithm's output against a known physical ground truth. The "human-in-the-loop" (i.e., the surgeon) is involved in using the device in the simulated use, but the fundamental accuracy measurements of the system itself are determined in a standalone fashion on the bench.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Testing: Engineering/mechanical ground truth based on precise fixtures and instrumentation (e.g., known angles).
- Simulated Use (Cadaver) Testing: "Predetermined clinical pass/fail criteria" validated by an "advising surgeon." The specific method for establishing objective ground truth (e.g., post-operative imaging, physical measurement) in the cadavers is not detailed.
The sample size for the training set:
- Not applicable/Not specified. This device is a computer-assisted surgical navigation system, using sensors (gyroscopes, accelerometers) to generate real-time angular measurements. The summary does not imply that it uses machine learning/AI models that require a "training set" in the conventional sense of image classification or predictive analytics. Its "algorithm" is likely deterministic (physics-based calculations from sensor data) rather than data-driven in the ML/AI context.
How the ground truth for the training set was established:
- Not applicable/Not specified. No training set for an AI/ML model is mentioned.

Summary

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December 10, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Navbit Pty Ltd % Elizabeth O'Keeffe, PhD Director of Regulatory Affairs Secure BioMed Evaluations 7828 Hickorv Flat Highway Suite 120 Woodstock, Georgia 30188

Re: K200376

Trade/Device Name: Navbit Sprint Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 11, 2020 Received: November 12, 2020

Dear Elizabeth O'Keeffe:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (QS) 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 mediation-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,

For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

510(k) Number (if known)

K200376

Device Name Navbit® Sprint

Indications for Use (Describe)

For Lateral Patient Registration:

The Navbit® Sprint System is a computer-controlled system intended to assist the surgeon in relation to reference axes during orthopedic surgical procedures. The Navbit® Sprint System facilitates the accurate positioning of implants, relative to these alignment axes.

The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a lateral decubitus position.

The Navbit® Sprint System for lateral patient registration is indicated for use:

. in Hip Arthroplasty surgical procedures;
with acetabular cups that are uncemented and allow for post-impaction correction; .
when post-impaction confirmatory measurement checks can be obtained.

For Supine Patient Registration:

The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a supine position.

The Navbit® Sprint System for supine patient registration is indicated for use:

in Hip Arthroplasty surgical procedures; .
with acetabular cups that are uncemented and allow for post-impaction correction; .
. when post-impaction confirmatory measurement checks can be obtained.

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

図 Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)

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5. 510(k) Summary

510(k) Summary - Navbit® Sprint
Required	By section 21 CFR 807.92 (c)
Date Prepared	14th February, 2020
Owners Name	David Thomson QA/RA Manager
Submitter	Navbit LtdSuite 1A, Level 1, 136 Willoughby RoadCrows Nest 2065, Australia
Official Contact	Secure BioMed EvaluationsElizabeth O'Keeffe, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681 (direct)855-MED-DEV1 (office)Regulatory@SecureBME.com
Product Codes	OLO: Orthopedic Stereotaxic Instrument
Class	II
Classification Reference	21 CFR 882.4560
Common/Usual Name	Stereotaxic instrument.
Proprietary Name	Navbit® Sprint
Predicate Device(s)	OrthAlign Plus® System (K172462)
Reason for submission	New Device

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5.1. Intended Use and Indications for Use:

For Lateral Patient Registration:

The Navbit® Sprint System is a computer-controlled system intended to assist the surgeon in determining alignment in relation to reference axes during orthopedic surgical procedures. The Navbit® Sprint System facilitates the accurate positioning of implants, relative to these alignment axes.

The Navbit® Sprint System for lateral patient registration is indicated for use:

in Hip Arthroplasty surgical procedures;
. with acetabular cups that are uncemented and allow for post-impaction correction;
. when post-impaction confirmatory measurement checks can be obtained.

For Supine Patient Registration:

The clinical setting and target population for the Navbit® Sprint System is that of a patient undergoing a Hip Arthroplasty surgical procedure by any approach with the patient in a supine position.

The Navbit® Sprint System for supine patient registration is indicated for use:

. in Hip Arthroplasty surgical procedures;
. with acetabular cups that are uncemented and allow for post-impaction correction;
when post-impaction confirmatory measurement checks can be obtained.

5.2. Device Description

During hip arthroplasty procedures, the Navbit® Sprint System assists the surgeon in registering the pelvic coordinate system and determining the inclination angle and the anteversion angle of the introducer/impactor relative to the registered pelvic coordinate system.

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The device requires registration to be performed in one of two acceptable patient positions - supine and lateral, and alignment guidelines are provided for each. Any surgical approach that allows this registration to be performed is appropriate for use with the Navbit® Sprint.

The Navbit® Sprint System is provided terminally sterilized, single-use disposable.

5.3. Characteristics between predicate and new device

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Table 1: Comparison between Predicate Device OrthAlign Plus® System (K172462) and Navbit® Sprint System

5.4. Substantial Equivalence

As a result of the Risk Analysis review and design input requirements, verification activities were performed on the Navbit® Sprint System. All tests confirmed the product met the predetermined acceptance criteria. This included testing against the FDA consensus standard, ASTM F2554-18 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. Navbit has determined the Navbit® Sprint System to be as safe and effective as the predicate device [OrthAlign Plus® System (K172462)].

ર. ર. Performance Data

Device performance testing confirms that the Navbit® Sprint System can be used according to its intended use. The Navbit® Sprint System has been verified and validated according to Navbit procedures for product design and development. Performance testing addressed the functionality and surgical procedure workflows/steps as defined in the Navbit® Sprint user manual and demonstrates that the Navbit® Sprint System is as safe, as effective, and performs as well as the predicate device [OrthAlign Plus® System (K172462)].

5.6. Non-Clinical Testing

All non-clinical testing was performed to demonstrate the equivalence of the subject device, and all testing met the predetermined acceptance criteria.

Non-clinical testing included:

. Software verification and validation to ensure the integrity of the code and functionality including reliability of the software in various use sequences.

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Image /page/8/Picture/0 description: The image shows the word "NAVBIT" in all caps. The font is a simple sans-serif font. The letters are evenly spaced and the word is centered.

. System hardware verification/validation testing to ensure the Navbit® Sprint Device and its instruments meet their mechanical requirements.
Instrumentation cleaning, sterilization and shipping validations or adoptions for the specified processes.
. System components biocompatibility assessment per ISO 10993-1:2018.
System accuracy testing: bench testing with mechanical fixtures to verify angular measurement accuracy using ASTM F2554-18.
Simulated use (cadaver) testing of the Navbit® Sprint System with an advising surgeon to validate that the system meets the requirements for user needs in a simulated use environment provides validation evidence that the product met the predetermined clinical pass/fail criteria.

5.7. Clinical Testing

No clinical trial required. Simulated use testing on cadavers performed.

5.8. Animal Studies

No animal studies were performed for the Navbit® Sprint system.

5.9. Conclusion

The Navbit® Sprint System is substantially equivalent the predicate device OrthAlign Plus® System (K172462). Testing against the FDA consensus performance standard (ASTM F2554-18) and clinical validation using cadaver models has demonstrated that the Navbit® Sprint is as safe and as effective as the predicate device.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).

Trait	Subject Device: Navbit® Sprint	Predicate Device: OrthAlign Plus®	Comparison
510(k) number	K200376	K172462(prior clearance as K130387)	N/A
FDA Regulation	822.4560	822.4560	Equivalent
Product Code	OLO	OLO	Equivalent
ProductClassification	Class II	Class II	Equivalent
Use	Prescription Use / Rx OnlyPart 21 CFR 801 Subpart D	Prescription Use / Rx OnlyPart 21 CFR 801 Subpart D	Equivalent
Indications forUse	The Navbit® Sprint System is acomputer-controlled system intendedto assist the surgeon in determiningalignment in relation to reference axesduring orthopedic surgical procedures.The Navbit® Sprint System facilitatesthe accurate positioning of implants,relative to these alignment axes.The clinical setting and targetpopulation for the Navbit® SprintSystem is that of a patient undergoinga Hip Arthroplasty surgical procedureby any approach with the patient in alateral decubitus /supine position.The Navbit® Sprint System forlateral/supine patient registration isindicated for use:in Hip Arthroplasty surgicalprocedures; with acetabular cups that areuncemented and allow forpost-impaction correction; when post-impactionconfirmatory measurementchecks can be obtained.	The OrthAlign Plus® System is acomputer-controlled system intendedto assist to the surgeon in determiningreference alignment axes in relation toanatomical and instrumentationstructures during stereotacticorthopedic surgical procedures. TheOrthAlign Plus® System facilitates theaccurate positioning of implants,relative to these alignment axes. Thesystem aids the surgeon in controllingleg length and offset discrepancies inTotal Hip Arthroplasty. Ligamentbalancing is provided by the OrthAlignPlus® System in primary revision TotalKnee Arthroplasty.Example orthopedic surgicalprocedures include but are not limitedto:Total Knee Arthroplasty Total Hip Arthroplasty:Anterior/Posterior Unicompartmental KneeArthroplasty: Tibial transverseresection Ligament Balancing	EquivalentNavbit does notperform functionsassociated withknees, leg lengthand offset
Trait	Subject Device: Navbit® Sprint	Predicate Device: OrthAlign Plus®	Comparison
Principle ofOperation	Computer-assisted navigation system	Computer-assisted navigation system	Equivalent
Single Use	Yes	Yes	Equivalent
Location of Use	Hospital / Operating Theatre	Hospital / Operating Theatre	Equivalent
Biocompatibility	Per ISO 10993-1, ExternallyCommunicating Device,Tissue/Bone/Dentin Communicating,with subsystems that have direct andpotential indirect contact for a limitedcontact duration (< 24 hours)	Per ISO 10993-1, ExternallyCommunicating Device,Tissue/Bone/Dentin Communicating,with subsystems that have direct andpotential indirect contact for a limitedcontact duration (< 24 hours)	Equivalent
Materials	Stainless Steel grades common to orthopedic surgical instruments Polymer grades common to orthopedic surgical instruments Internal electronics	Stainless Steel grades common to orthopedic surgical instruments Polymer grades common to orthopedic surgical instruments Internal electronics	Equivalent
ControlMechanism	Computer generation of positionalinformation, using inertial sensors,microcontroller, digital signalprocessor and physical positions ofregistration instruments.	Computer generation of positionalinformation, using inertial sensors,microcontroller, digital signalprocessor and physical positions ofregistration instruments.	Equivalent
OperatingPrinciples;Registration ofAnatomy	Electronics attached to movableinstruments, placed in specifiedprocedural positions, on or in contactwith bony anatomy, for recordingsensor data.	Electronics attached to movableinstruments, placed in specifiedprocedural positions, on or in contactwith bony anatomy, for recordingsensor data.	Equivalent
Measurementand Navigation	Computer derived values. Accelerometer and rate gyroscope measurement of orientation of instrument.	Computer derived values. Accelerometer and rate gyroscope measurement of orientation of instrument. Linear encoder reading of probe position (for distance to determine position).	EquivalentNavbit does notsupportpositionalmeasurements
Main SystemComponents	Single-use computer unit Navigation and measurement software Single Use instrument sets (provided with disposable kit)	Single-use computer unit Navigation and measurement software Reusable instrument sets (provided as separate instrument set)	Equivalent
User Interface	Integrated graphical user interface, onan electronic unit that attaches toinstrumentation	Integrated graphical user interface, onan electronic unit that attaches toinstrumentation.	Equivalent
Energy Type	Two internal IEC-FR03 (ANSI 24-LF) Chemistry: Lithium/Iron Disulfide (Li/FeS2) Voltage: 3V (series) Storage Temp.: -40°C to 60°C Operating Temp.: -40°C to 60°C	One provided IEC-CR2, installed into Navigation Unit by user. Chemistry: Lithium/Manganese Dioxide (Li/MnO2) Voltage: 3V Storage Temp.: -40°C to 60°C Operating Temp.: -40°C to 60°C	Equivalent
Trait	Subject Device: Navbit® Sprint	Predicate Device: OrthAlign Plus®	Comparison
Sterilization	• Navigation unit: EO sterilization.• Instruments (Pins): EO sterilization.	• Navigation unit: EO sterilization.• Instruments: autoclave sterilization.	EquivalentNavbit® SprintDevice and BonePins are suppliedsterile
Registration	Registration required using pins fixed to the hip.	Registration required using pins fixed to the hip.	Equivalent
PatientInterface(i.e. Bone Pins)	• Instrument fixation to pelvic bone with pins.• Pin diameter of 4.0 mm, pin length of 125.0 mm• 316L surgical Stainless Steel (ASTM 138)	• Instrument fixation to pelvic bone with pins and screws.• Pin diameter 5/32" (4.0 mm), pin length 110.0 mm.• 316L surgical Stainless Steel (ASTM 138)	EquivalentVariations in pinlength dictatedby differentinterfacingequipment,equivalentpatient/threadengagement
Environmentalspecifications	Specified storage and operating environments for typical transport and surgical environments	Specified storage and operating environments for typical transport and surgical environments.	Equivalent