Who is the manufacturer of XLO Brand of Locking Distal Humerus Plating System?

Ortho Life Systems Private Limited filed the 510(k) submission for XLO Brand of Locking Distal Humerus Plating System (K233873).

What is the FDA product code for XLO Brand of Locking Distal Humerus Plating System?

HRS. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for XLO Brand of Locking Distal Humerus Plating System?

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

Who can help prepare an FDA 510(k) submission like XLO Brand of Locking Distal Humerus Plating System?

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.

XLO Brand of Locking Distal Humerus Plating System

Q: What are the predicate devices for XLO Brand of Locking Distal Humerus Plating System?

Synthes Variable Angle LCP Elbow System (K120717); Synthes 3.5mm LCP Distal Humerus System (K033995); Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684); Synthes Cortical Screws (K112583).

K233873 · Ortho Life Systems Private Limited · HRS · Apr 26, 2024 · Orthopedic

Device Facts

Record ID	K233873
Device Name	XLO Brand of Locking Distal Humerus Plating System
Applicant	Ortho Life Systems Private Limited
Product Code	HRS · Orthopedic
Decision Date	Apr 26, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The XLO Brand of Locking Distal Humerus Plating System are indicated for intraarticular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus. The system is indicated for use in adult patients only. All implants are for single use only.

Device Story

System comprises titanium-alloy (Ti-6Al-4V) bone plates and screws for fixation of distal humerus fractures. Plates feature compression, locking, and non-locking holes; screws include cortical, locking, and self-tapping variants. Designed based on bone contour and anatomy. Implants are provided non-sterile and require moist heat sterilization by the user. Used by orthopedic surgeons in clinical settings to stabilize bone fractures, osteotomies, or non-unions. Output is mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including static four-point bend testing for plates (ASTM F382) and torsional strength, driving torque, removal torque, and axial pull-out strength testing for screws (ASTM F543).

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136). Components: Locking/non-locking plates and screws. Sterilization: Moist heat (ANSI/AAMI/ISO 17665-1). Mechanical testing: ASTM F382 (plates), ASTM F543 (screws).

Indications for Use

Indicated for adult patients with intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.

Regulatory Classification

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.

Predicate Devices

Synthes Variable Angle LCP Elbow System (K120717)
Synthes 3.5mm LCP Distal Humerus System (K033995)
Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684)
Synthes Cortical Screws (K112583)

Related Devices

K120070 — SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM · Synthes USA · Mar 21, 2012
K063095 — HUMERUS LOCKING PLATING SYSTEM · Newclip Technics · Dec 22, 2006
K213895 — Distal Humerus Plating System · Skeletal Dynamics, Inc. · Jan 13, 2022
K213108 — Humerus & Ulna System · Auxein Medical Private Limited · Nov 4, 2022
K143697 — Biomet Proximal Humerus Plating System · Biomet Manufacturing · Mar 30, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ April 26, 2024 Image /page/0/Picture/1 description: The image shows 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. Ortho Life Systems Private Limited Tamandeep Kochhar Director D-111, Okhla Industrial Area, Phase 1 New Delhi Okhla, Delhi 110020 India Re: K233873 Trade/Device Name: XLO Brand of Locking Distal Humerus Plating 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, HWC Dated: March 28, 2024 Received: March 28, 2024 Dear Tamandeep Kochhar: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, # Shumaya Ali -S Shumaya Ali, MPH 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K233873 Device Name XLO Brand of Locking Distal Humerus Plating System Indications for Use (Describe) The XLO Brand of Locking Distal Humerus Plating System is indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus. The system is indicated for use in adult patients only. All implants are for single use only. | 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}------------------------------------------------ # K233873 510(k) Summary Premarket Notification 510(k) Summary as required by Section 807.92 General Company Information as required by 807.92 (a) ## (a.1). The submitter's name, address, telephone number, a contact person, and the date the summary was prepared | Submitter's Name: | Ortho Life Systems Pvt. Ltd. | |----------------------|----------------------------------------------------------------| | Address: | D-111, Okhla Industrial Area, Phase 1, New Delhi-110020, India | | Contact Person Name: | Mr. Tamandeep Singh Kochhar | | Title: | Director | | Phone Number: | +91-11-41324393 | | Dated: | April 25, 2024 | Throughout the submission there is a mention of XLO Brand of Locking Distal Humerus Plating System that represents the range of products covered under this 510(k) submission. ## (a.2). The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known ## Proprietary Name: - . XLO Brand of Locking Distal Humerus Plating System ## Common or Usual Name: - PLATES, FIXATION, BONE - . SCREWS, FIXATION, BONE #### Classification Name: - Orthopedic Bone Plates - . Orthopedic Bone Screws #### Classification Product Code: HRS, HWC Device Class: Il Review Pane: Orthopedic {4}------------------------------------------------ ## Regulation Description: - Single/multiple component metallic bone fixation appliances and accessories - Smooth or threaded metallic bone fixation fastener Regulation Number: 21 CFR 888.3030 (primary) and 21 CFR 888.3040 ## (a.3). Identification of the Predicate Device: Following are the predicate device 510(k) with which we are claiming substantial equivalence: #### Primary Predicate Device: - Synthes Variable Angle LCP Elbow System (K120717) #### Additional Predicate Devices: - Synthes 3.5mm LCP Distal Humerus System (K033995) ● - Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684) - Synthes Cortical Screws (K112583) ## (a.4). A description of the device that is the subject of the premarket notification submission, such as might be found in the labeling or promotional material for the device #### Device Description: #### Plate Fixation System The XLO Brand of Locking Distal Humerus Plating System consists of various shape and sizes of plates featuring compression and locking or non-locking holes, full threaded-cortical, locking or non-locking & self-tapping screws. The XLO Brand of Locking Distal Humerus Plating System consists of the following implants: - Distal Humerus Locking Plate 2.7/3.5, Dorsolateral, Left & Right - Distal Humerus Locking Plate 2.7/3.5, Dorsolateral, With Lateral Support Left & Right - 3.5mm cortical screw - 2.7mm locking screw - 3.5mm locking screw The aforementioned plates are used with cortical screws & locking Screws. These bone plates are generally designed on the basis of the bone contour and anatomy. The plates and screws are fabricated from titanium-alloy (Ti-6Al-4V). #### These implants are sold non-sterile, the products have to be sterilized prior to use. {5}------------------------------------------------ ## (a.5). A statement of the intended use of the device ## Indications for Use: The XLO Brand of Locking Distal Humerus Plating System are indicated for intraarticular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus. The system is indicated for use in adult patients only. All implants are for single use only. ## (a.6). Summary of Technological Characteristics as compared to the predicate devices: #### Substantial equivalence including comparison with predicate devices A comparison between the XLO Brand of Locking Distal Humerus Plating System and predicate devices has been performed which has resulted in demonstration of similarities in dimensional and performance criteria. | S. No. | Characteristics | Predicate Device Versus New Device (XLO Brand) | Remarks | |--------|-----------------------------|--------------------------------------------------------------------------------------------------|------------| | 01 | Indications for use | Same intended use and similar Indications for Use in New Device and Predicate device | Equivalent | | 02 | Material | Same material used in New Device and Predicate device | Equivalent | | 03 | Performance Standards | Same performance standards used in both New Device as well as predicate device | Equivalent | | 04 | Dimensional Verification | Same dimensions found in both New Device as well as Predicate device | Equivalent | #### Following is the summary of parameters in which the comparison has been verified: ## (b.1): Discussion on the non-clinical testing performed Following are the applicable product standards considered for non-clinical standards - A: Material Standards - B: Performance Standards #### A: Material Standards: The following material standards were used to manufacture the subject metallic surgical implants. {6}------------------------------------------------ - 1. ASTM F136: Standard specification for wrought Titanium-6Aluminium-4Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications. We have verified the purchased material is in compliance with these standards. ## B: Performance Standards: The device performance of XLO Brand of Locking Distal Humerus Plating System has been demonstrated against following applicable standards - . ASTM F382, - ASTM F543. The subject device test results were compared to the performance criteria outlined in FDA guidance documents, "Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway" and "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway". ## (b.2). Discussion on the clinical evaluation referenced and relied upon: Clinical data and conclusions were not needed for these devices to demonstrate substantial equivalence to the predicate devices. ## (b.3). CONCLUSION: #### General, Safety and Performance conclusion: | S. No. | Parameter of Conclusion | Proposed Device | Predicate Device | |--------|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | 01 | Product Code | For Bone Plates: HRS For Bone Screws: HWC | Same | | 02 | Regulation Number | For Bone Plates: 21CFR 888.3030 For Bone Screws: 21CFR 888.3040 | Same | | 03 | Regulatory Class | Class II | Same | | 04 | Intended Use | Same as mentioned in Point (a.6) above. | Same Intended Use | | 05 | Sterilization | Provided Non-Sterile and to be sterilized using Moist Heat Sterilization Method to achieve SAL of 10-6 as validated per ANSI/AAMI/ISO 17665- 1:2006/(R) 2013, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and control of a sterilization process for medical devices. | Same | {7}------------------------------------------------ | 06 | Mechanical Test Performance | For Bone Plates: Subject device plates were tested per ASTM F382 Static Four Point Bend Test. The test results conform to the performance criteria outlined in FDA guidance document, "Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway". For Bone Screws: Subject device screws were tested per ASTM F543 for Torsional Strength, Driving Torque, Removal Torque, and assessed for Axial Pull-out Strength. The results conform to the performance criteria outlined in FDA guidance document, “Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway". | Same | |----|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | 07 | Material Standards | ASTM F136 | Same | From the available data available we can justify that the XLO Brand of Locking Distal Humerus Plating System are as safe, as effective and perform as same indications for use as that of already marketed predicate devices identified in (a.3) of 510(k) summary. Hence our devices can be considered safe and effective for their intended use.