(141 days)
Not Found
No
The device description focuses on the mechanical components (plates and screws) and their material properties, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are based on mechanical testing standards.
Yes
This device is a surgical implant used to fix fractures and treat other bone conditions in the distal humerus, which is a therapeutic intervention.
No
This device is a plating system designed for the internal fixation of fractures and non-unions of the distal humerus, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical implants (plates and screws) made of titanium-alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The XLO Brand of Locking Distal Humerus Plating System is a system of plates and screws made of titanium alloy. These are implants designed to be surgically inserted into the body to fix bone fractures.
- Intended Use: The intended use is for the surgical treatment of fractures and other conditions of the distal humerus. This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The device is a surgical implant used for orthopedic fracture fixation, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
HRS, HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal humerus
Indicated Patient Age Range
adult patients only
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed based on material standards ASTM F136 and performance standards ASTM F382 and ASTM F543.
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".
Clinical data and conclusions were not needed for these devices to demonstrate substantial equivalence to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K120717, K033995, K000684, K112583
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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) |
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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
-
- 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.
- ASTM F136: Standard specification for wrought Titanium-6Aluminium-4Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.
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.