The LOQTEQ® Proximal Humerus Plate 3.5 System is intended for fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone.

Device Description

The subject device includes a total of nine (9) bones plates for internal fixation of bone fragments. i.e., for treatment of bone fracture and other bone injuries. All LOOTEO® Proximal Humerus Plate 3.5 are available non-sterile.

The subject device is provided in anatomic designs in overall lengths of 85 mm, 92 mm, 105 mm, 118 mm. 143 mm. 169 mm. 195 mm. 221 mm. and 247 mm. The plates are provided with 3, 4, 5, 6. 8, 10, 12, 14, and 16 holes, respectively, in plate. The lengths of 92 mm, 118 mm, 143 mm, 169 mm, and 195 mm are identical to the plates previously cleared in K121495. Subject device lengths of 85 mm, 221 mm, and 247 mm are identical to the plates previously cleared in K121495 except for the length and number of holes.

The subject device plates include screw holes designed to accommodate appropriately sized locking and non-locking cortical and periprosthetic bone screws, previously cleared in K121495, and K-wires cleared in K131459, presented marked as part of the LOQTEQ® Proximal Humerus Plate 3.5 System. The compatible screws are 3.5 mm in diameter. The subject device plates are also compatible with the 1.6 mm diameter app K-Wires.

AI/ML Overview

The provided text, K211582, describes a 510(k) premarket notification for a medical device: the LOQTEQ® Proximal Humerus Plate 3.5 System. It explicitly states that no clinical data were submitted for this premarket notification (see sections titled "PERFORMANCE DATA" and the summary at the end of section {7}). Instead, substantial equivalence was demonstrated based on non-clinical testing.

Therefore, many of the requested items related to clinical study design, such as acceptance criteria, sample size for test sets, expert ground truth establishment, MRMC studies, and training set details, are not applicable to this submission.

However, I can extract information related to the performance data that was provided and how the device met the requirements for substantial equivalence.

Here's a breakdown of the information based on your request, as much as can be gleaned from the provided text:

Acceptance Criteria and Device Performance (Non-Clinical)

The acceptance criteria for this device are not framed in terms of clinical performance metrics (e.g., sensitivity, specificity) as it's not an AI/diagnostic device or a device requiring clinical trial for performance. Instead, the acceptance criteria are based on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical testing, ensuring the new device does not raise new questions of safety or effectiveness.

The "performance" of the device is assessed by its equivalence in key technological characteristics and biomechanical performance to its predicates.

Table of Acceptance Criteria (Implied for Substantial Equivalence) and Reported Device "Performance":

Acceptance Criteria Category (Derived from Substantial Equivalence Requirements)	Stated Method of Meeting Criteria / Reported Device "Performance"
Indications for Use (IFU) Equivalence	Met: The subject device has similar Indications for Use Statements (IFUS) to those of devices previously cleared in K121495 (primary predicate) and K041860 (additional predicate). Differences in the IFUS (e.g., removing descriptive text about the device) were stated not to impact substantial equivalence as all IFUS express the same intended use.
Technological Characteristics Equivalence (General)	Met: The subject device, the primary predicate device (K121495), and the additional predicate device (K041860) have the same technological characteristics (e.g., design principles for bone fixation, use of locking/non-locking screws). Differences do not impact substantial equivalence.
Biocompatibility	Met: Biocompatibility was referenced from the previous submission K121495. The subject device components are manufactured in the same facilities, using identical materials (Ti-6Al-4V alloy, ASTM F136) and manufacturing processes as the previously cleared aap device components (K121494 and K121495). Therefore, the devices are considered substantially equivalent regarding biocompatibility.
Sterilization	Met: The device is provided non-sterile and is intended to be sterilized by the end user via moist heat to a sterility assurance level (SAL) of 10⁻⁶. This method and parameters are identical to those used for devices previously cleared in K121495. Validation of the recommended end-user moist heat sterilization cycle was performed according to ANSI AAMI ISO 17665-1. The subject devices do not represent a new worst case for sterilization validation.
Biomechanical Performance	Met: An assessment of the biomechanical performance was performed based on cross-sectional analysis of the subject device as compared to the predicate device plates in submission K1214495. The new lengths (85 mm, 221 mm, 247 mm) are stated to have "identical design characteristics as plates cleared in K121495" and "encompass a similar range of dimensions as K041860 (secondary predicate)." Importantly, the submission concludes: "These two new lengths do not create a new worst case for mechanical testing." This implies that their mechanical performance is deemed equivalent or superior to the existing cleared devices, or at least within acceptable limits without requiring further specific mechanical testing data for these new sizes, based on the cross-sectional analysis and comparison to existing data. The predicate K041860 was referenced for "comparison mechanical testing" (though no new mechanical testing data was submitted here).
Manufacturing Process/Materials Equivalence	Met: The subject device and primary predicate device (K121495) are manufactured from identical titanium alloy material (ASTM F136). All subject device final finished components are manufactured in the same facilities using identical materials and identical manufacturing processes as used for previously cleared aap device components (K121494).
Physical Dimensions/Design Features Equivalence	Met: While some new lengths are introduced, the new lengths (85 mm, 221 mm, and 247 mm) have "identical design characteristics as plates cleared in K121495" and encompass a similar range of dimensions as the additional predicate (K041860). Core design features like hole types (gliding-holes, round holes) are identical to the primary predicate.

Study Details (as inferable for a non-clinical 510(k))

Sample sizes used for the test set and the data provenance:
- Test Set (Non-Clinical): Not directly defined in terms of a "test set" for a clinical study. The "test" here refers to the comparisons against predicate devices. The "sample" is the set of subject device configurations (9 plate lengths) and their features.
- Data Provenance: The data referenced (biocompatibility, sterilization validation, biomechanical cross-sectional analysis) is from non-clinical testing and previous 510(k) submissions (K121495, K131459, K121494) for the manufacturer's own predicate devices. The country of origin for this testing is not specified, but the manufacturer is aap Implantate AG in Berlin, Germany. The data is retrospective in the sense that it relies heavily on previously established equivalence for predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a non-clinical substantial equivalence submission. There is no "ground truth" to be established by experts in the context of clinical performance or diagnosis. The "truth" is established by adherence to standards and comparison to cleared predicates.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No expert adjudication was relevant for this type of submission.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a bone fixation device, not an AI/diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the clinical sense. The "ground truth" for substantial equivalence is derived from:
  - Compliance with recognized standards (e.g., ANSI AAMI ISO 17665-1 for sterilization, ASTM F136 for material).
  - Previously cleared predicate devices whose safety and effectiveness are already established by the FDA.
  - Engineering analysis (cross-sectional analysis for biomechanical performance).
The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not Applicable.

Summary

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October 18, 2021

aap Implantate AG % Melissa Burbage Sr. Regulatory Specialist PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K211582

Trade/Device Name: LOQTEQ® Proximal Humerus Plate 3.5 System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: May 19, 2021 Received: May 21, 2021

Dear Melissa Burbage:

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.

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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 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 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.

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

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Indications for Use

510(k) Number (if known)

K211582

Device Name

LOQTEQ® Proximal Humerus Plate 3.5 System

Indications for Use (Describe)

The LOQTEQ® Proximal Humerus Plate 3.5 System is intended for fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone.

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)

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510(k) Summary

K211582

LOQTEQ® Proximal Humerus Plate 3.5 System

aap Implantate AG

October 15, 2021

ADMINISTRATIVE INFORMATION

Manufacturer Name	aap Implantate AGLorenzweg 512099 Berlin GermanyTelephone: +49 30 75019129Fax: +49 30 75019111
Official Contact	Agnieszka Mierzejewska, Chief Operating Officer
Representative/Consultant	Melissa BurbageKevin A. Thomas, PhD; Floyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone: +1 858-792-1235Fax: +1 858-792-1236Email: mburbage@paxmed.com kthomas@paxmed.com; flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Device Name	LOQTEQ® Proximal Humerus Plate 3.5 System
Common Name	Plate, Fixation, Bone
Regulation Number	21 CFR 888.3030
Regulation Name	Single/multiple component metallic bone fixation appliances andaccessories
Regulatory Class	Class II
Product Code	HRS
Classification Panel	Orthopedic
Reviewing Division	Office of Orthopedic Devices (OHT6)Division of Restorative, Repair and Trauma Devices (DHT6C)Stereotaxic, Bone Growth Stimulators and Fracture FixationDevices Team

PREDICATE DEVICE INFORMATION

Primary Predicate K121495, aap LOQTEQ® Proximal Humerus Plate 3.5 System Additional Predicate K041860, Synthes LCP Proximal Humerus Plate, Long

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INDICATIONS FOR USE STATEMENT

The LOQTEQ® Proximal Humerus Plate 3.5 System is intended for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone.

SUBJECT DEVICE DESCRIPTION

PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include biocompatibility referenced from K121495; validation of the recommended end-user moist heat sterilization cycle according to ANSI AAMI ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. An assessment of the biomechanical performance of the subject device to determine substantial equivalence was performed based on cross sectional analysis of the subject device as compared to the predicate device plates in submission K121495. Clinical data were not submitted in this premarket notification.

COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES

The primary predicate device is the manufacture's own device K121495, aap LOQTEQ® Proximal Humerus Plate 3.5 System. The additional predicate device is K041860, Synthes LCP Proximal Humerus Plate, Long, Synthes (USA).

The subject device is substantially equivalent in indications and design principles to the predicate devices listed above. The subject device has similar Indications for Use Statements (IFUS) to those of devices previously cleared in K121495 and K041860. Differences between the subject device and primary predicate device K121495 include the statement "The aap LOQTEQ®

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Proximal Humerus Plate 3.5 System includes LOQTEQ® Proximal Humerus Plate 3.5 short and LOQTEQ® Proximal Humerus Plate 3.5 long. The plates accept 3.5 mm cortical locking screws and 3.5 mm cortical screws as well as 3.8 mm cancellous locking screws." The statement was removed from the subject device IFUS because the statement describes the device rather than defining "... the disease or condition the device will diagnose, treat, prevent, cure or mitigate, including a description of the patient population for which the device is intended" per 21 CFR §814.20(b)(3)(i). The compatibility of the subject device plates and previously cleared screws is described in the Instructions for Use and Surgical Technique. Differences between the subject device and the additional predicate device K041860 are limited to the device trade or proprietary name. These differences do not impact the substantial equivalence because all IFUS express the same intended use for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone.

The subject device, the primary predicate device K121495, and the additional predicate device K041860 have the same technological characteristics and use the same operating principles for bone fixation. Furthermore, the subject device, the primary predicate device, and the additional predicate device include similar anatomic designs for placement on the proximal humerus, with screw holes to accommodate locking and non-locking screws. The subject device designs in lengths of 92 mm, 105 mm, 118 mm, 169 mm, and 195 mm with 4, 5, 6, 8,10, and 12 holes, respectively, are identical to the plates cleared in K121495. Subject device lengths of 85 mm, 221 mm, and 247 mm, with 3, 14 and 16 holes, respectively, have identical design characteristics as plates cleared in K121495, and encompass a similar range of dimensions as K041860 (secondary predicate). These two new lengths do not create a new worst case for mechanical testing.

The subject device and the primary predicate device K121495 are manufactured from the identical titanium alloy material conforming to ASTM F136. All subject device final finished components are manufactured in the same facilities using identical materials and identical manufacturing processes as used for the previously cleared aap device components (K121494). Similarly, the Class II device-specific accessories and Class I instruments are manufactured in the same facilities using identical materials and identical manufacturing processes as the Class II accessories and Class I instruments previously cleared in K121495. Therefore, the subject devices are substantially equivalent to K121495 regarding biocompatibility.

The subject device includes components provided non-sterile in the same packaging and are to be sterilized to a sterility assurance level (SAL) of 10 by the end user using the same sterilization method (moist heat) and parameters as devices previously cleared in K121495. The subject devices do not represent a new worst case for the sterilization validation.

Feature	Subject Device	Primary Predicate Device	Additional Predicate Device
	K211582	K121495	K041860
	LOQTEQ Proximal HumerusPlates 3.5	LOQTEQ Proximal HumerusPlates 3.5	Synthes LCP Proximal HumerusPlates, Long
	aap Implantate AG	aap Implantate AG	Synthes USA
	Product Code	HRS	HRS, HWC
Indications for Use	The LOQTEQ Proximal HumerusPlate 3.5 System is intended forfractures and fracture dislocations,osteotomies, and nonunions of theproximal humerus, particularly inosteopenic bone.	The aap LOQTEQ Proximal HumerusPlate 3.5 System includes LOQTEQProximal Humerus Plate 3.5 short andLOQTEQ Proximal Humerus Plate 3.5long. The plates accept 3.5 mm corticallocking screws and 3.5 mm cortical	Synthes (USA) LCP ProximalHumerus Plate, long is indicated forfractures and fracture dislocations,osteotomies, and nonunions of theproximal humerus, particularly inosteopenic bone.
Feature	Subject DeviceK211582LOQTEQ Proximal HumerusPlates 3.5aap Implantate AG	Primary Predicate DeviceK121495LOQTEQ Proximal HumerusPlates 3.5aap Implantate AG	Additional Predicate DeviceK041860Synthes LCP Proximal HumerusPlates, LongSynthes USA
		screws as well as 3.8 mm cancellouslocking screws.The LOQTEQ Proximal Humerus Plate3.5 System is intended for fractures andfracture dislocations, osteotomies, andnonunions of the proximal humerus,particularly in osteopenic bone.
Reason forPredicate/ReferenceDevice	Not applicable	Plate designs, including use withlocking and non-locking screws;Compatible screws;Materials ASTM F136	Plate length, plate designs,including use with locking andnon-locking screws;Reference devices forcomparison mechanical testing:
Plate Materials	Ti-6Al-4V alloy, ASTM F136	Ti-6Al-4V alloy, ASTM F136	Ti-6Al-4VNb alloy or StainlessSteel 316L
Type of Holes	Gliding-holes(locking/compression)Round holes (locking only)	Gliding-holes(locking/compression)Round holes (locking only)	Gliding-holes(locking/compression)Round holes (locking only)
Plate Length	Short Plates3 holes, 85 mm4 holes, 92 mm5 holes, 105 mm6 holes 118 mmLong Plates8 holes, 143 mm10 holes, 169 mm12 holes, 195 mm14 holes, 221 mm16 holes, 247 mm	Short Plates4 holes, 92 mm5 holes, 105 mm6 holes 118 mmLong Plates8 holes, 143 mm10 holes, 169 mm12 holes, 195 mm	Short Plates3 holes, 90 mm5 holes, 114 mmLong Plates5 holes 142 mm6 holes, 160 mm8 holes, 196 mm10 holes, 232 mm12 holes, 268 mm
Head & ShaftDimensions	Short PlatesHead width: 23 mmHead thickness: 3.5 mmShaft width: 12 mmShaft thickness: 3.5 mmLong PlatesHead width: 23 mmHead thickness: 3.5 mmShaft width: 13 mmShaft thickness: 4.5 mm	Short PlatesHead width: 23 mmHead thickness: 3.5 mmShaft width: 12 mmShaft thickness: 3.5 mmLong PlatesHead width: 23 mmHead thickness: 3.5 mmShaft width: 13 mmShaft thickness: 4.5 mm	Short PlatesHead width: 20 mmHead thickness: 2.5 mmShaft width: 12 mmShaft thickness: 2.5 mmLong PlatesHead width: 20 mmHead thickness: 3.0 mmShaft width: 12 mmShaft thickness: 3.7 mm
Surface Treatment	Polished	Polished	Type III anodization
Screw Diameters	No new screwsCancellous screws:3.8 mm diameter, 28-60 mmlengthCortical screws, self-tapping:3.5 mm diameter, 18-38 mmlength	Cancellous screws:3.8 mm diameter, 28-60 mm lengthCortical screws, self-tapping:3.5 mm diameter, 18-38 mm length	Cancellous screws, fullythreaded:4.0 mm diameter, 10-60 mmlengthCancellous screws, partiallythreaded:4.0 mm diameter, 10-50 mmlengthCortex screws:3.5 mm diameter, 10-60 mmlength4.0 mm diameter, 10-60 mmlength (SS material only)Locking screws (SS material and
Feature	Subject DeviceK211582LOQTEQ Proximal HumerusPlates 3.5aap Implantate AG	Primary Predicate DeviceK121495LOQTEQ Proximal HumerusPlates 3.5aap Implantate AG	Additional Predicate DeviceK041860Synthes LCP Proximal HumerusPlates, LongSynthes USA
			Ti-6Al-4VNb alloy only):3.5 mm diameter, 10-60 length
Screw Materials	Ti-6Al-4V alloy, ASTM F136	Ti-6Al-4V alloy, ASTM F136	TiCP, Ti6Al7Nb, Ti-6Al-4Valloy, SS 316L
Surface Treatment	Anodized Type III (lockingcancellous screw green)Partially anodized Type III(locking compression screw)Anodized Type III (non-locking screws gold)	Anodized Type III (lockingcancellous screw green)Partially anodized Type III (lockingcompression screw)Anodized Type III (non-lockingscrews gold)	Anodized Type III (all screws)
How Provided
Sterility	Provided non-sterile	Provided non-sterile	Provided non-sterile andProvided sterile
Sterilization	Non-sterile: to be sterilized bymoist heat	Non-sterile: to be sterilized bymoist heat	Non-sterile: to be sterilized bymoist heatSterile: method not stated
Usage	Single-patient, single-use	Single-patient, single-use	Single-patient, single-use

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In summary, non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility referenced from K121495; validation of the recommended end-user moist heat sterilization cycle according to ANSI AAMI ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. An assessment of the biomechanical performance of the subject device to determine substantial equivalence was performed based on cross sectional analysis of the subject device as compared to the predicate device plates in submission K121495. Clinical data were not submitted in this premarket notification.

Any differences in the technological characteristics among the subject and predicate devices do not raise different questions of safety and effectiveness. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

CONCLUSION

The subject devices, the primary predicate device, and the additional predicate device have the same intended use and similar technological characteristics. They encompass a similar range of physical dimensions, are manufactured from the same materials, and are to be sterilized using identical methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.