(159 days)
Not Found
No
The device description focuses on the physical components (plates and screws) and their materials and dimensions. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML. The performance studies are based on mechanical testing of the implants.
Yes
The device is indicated for treating fractures of various bones, which is a therapeutic purpose.
No
The device, NEBULA BRAND Locking Bone Plates and Screws, is intended for treating fractures by providing osteosynthesis (surgical fixation of a fractured bone). It consists of plates and screws used to physically stabilize bones, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly details physical hardware components, including bone plates and screws made of stainless steel and titanium, with varying sizes and shapes. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is indicated for treating bone fractures. This is a therapeutic use, not a diagnostic one.
- Device Description: The device consists of bone plates and screws, which are implants used to stabilize bone fractures. This is consistent with a surgical device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies described (mechanical testing of plates and screws) are relevant to the structural integrity and function of a surgical implant, not the accuracy of a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are provided non-sterile.
NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are indicated for treating fractures of various bones including the clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).
The system is indicated for use in adult patients only. All implants are for single use only.
Product codes
HRS, HWC
Device Description
The NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System is submitted as a bundled submission. Throughout the submission there is a mention of NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System that represents the range of products covered under this 510(k) submission. The NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are subdivided into the following categories:
| S. No. | Category | Types |
|---|---|---|
| 01 | Mini, Small and Large | Volar Plates, T-Shaped, Angled Plates, |
| Reconstruction plates | ||
| 02 | Dynamic compression | Small, Narrow, Lengthening |
| 03 | Hip Plate | Dynamic Hip Screw Plates |
| 04 | Bone Screws | Locking and Non-Locking Version |
Generally, there are the following types of bone plates used with cortical (cortex), cancellous, and Locking Screws. These bone plates are generally designed on the basis of the bone contour and anatomy.
| S. No. | Type | Subtype |
|---|---|---|
| 01 | Mini, Small and Large | |
| Fragment | Volar Plates, T-Shaped, Angled Plates, | |
| Reconstruction plates | ||
| 02 | Dynamic compression | Small, Narrow, Lengthening Narrow, Broad Plates |
| 03 | Hip Plate | Dynamic Hip Screw Plates |
NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking selftapping screws, compression and dynamic screws.
The plates and screws are fabricated from Stainless Steel and Titanium. The implants are supplied non-sterile and should be steam-sterilized prior to use.
The system contains several models based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, and the ankle. The plate implants are available in models such as Reconstruction Plates, T- Plates, , Anatomical Plates, and Clavicle Plates.
These all are mainly divided into the following:
- . Large Fragment Plates
- Small Fragment Plates
- Hip Plates (DHS Plate)
The thickness of the plates varies from 1.3mm to 6mm; and the nomber of the holes varies from 2 to 20. The Locking screw implants are in corresponding diameter ranges from 2.7mm, and 4.9 mm diameters with lengths varying as per the requirements and lengths of 10mm to 90 mm
The Non-locking cortical screw implants are in 3.5mm diameter and length range from 10mm to 80mm.
The Non-locking cancellous screws are in 6.5mm diameter and length range from 30mm to 120mm The Non-locking cannulated cancellous screws are in 4.0mm diameter and length range from 10mm to 72mm
The Lag Screw is of 12.5mm Diameter and length from 50mm to 120mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges)
Indicated Patient Age Range
adult patients only
Intended User / Care Setting
Prescription Use
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 Performance Testing: NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are of similar design and pattern as well as similar information was not necessary to demonstrate substantial equivalence. Performance of the NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System has been demonstrated through the test parameters outlined in ASTM F-382 and ASTM F-384 to conduct Static and Dynamic Four Point Bend Testing. Torsional and Axial pullout testing was conducted on the screws per ASTM F-543.
Conclusion: From the data presented, the NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are substantially equivalent in performance for the indications and predicate devices identified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K953644, K082807, K001945, K051986, K111540, K033995, K073460, K092812, K032269, K030597, K961413, K062564, K011978, K041860, K923613S, K953607, K923613, K000684, K112583, K061621, K000682
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
December 9, 2019
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency's role in regulating and overseeing food and drug products in the United States.
Nebula Surgical Private Limited Rajat Kumar Khant Director Nebula, Narmada Park-3,Amin Marg, Vidyakunj Soc.Main Road Opp.Kings Heigt Rajkot, 360005 In
Re: K191793
Trade/Device Name: Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS 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: September 10, 2019 Received: September 10, 2019
Dear Rajat Khant:
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.
1
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, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191793
Device Name
Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System
Indications for Use (Describe)
NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are provided non-sterile.
NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are indicated for treating fractures of various bones including the clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).
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 201.2 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 201.2 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This Premarket Notification 510(k) Summary is prepared as required by Section 807.92
Submitter Information
| 510(k) Submitter:
Date Prepared: | NEBULA SURGICAL PVT. LTD.
06-06-2019 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Head Office Address: | "Nebula", Narmada Park-3, Vidyakunj Society Main Road, Opp. Kings Height
Appt., Amin Marg, Rajkot - 360005, Gujarat (INDIA) |
| Factory address : | G/1921/3, Gate no. 02, G.I.D.C. - Metoda, Dist. Rajkot - 360021, Gujarat (INDIA) |
| Contact: | Rajat Kumar Khant
Director (Sales and Marketing)
Email: executiveshrikant@gmail.com
Phone: +91-9825132632 |
Submission Information
| Proprietary Name: | NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System |
|---|---|
| Common or Usual Name: | Orthopaedic Bone Plates and Screws |
| Classification Name: | 21 CFR 888.3030: Plates Fixation, Bone |
| 21 CFR 888.3040: Screws, Fixation, Bone | |
| Product Code: | HRS, HWC |
| Device Class: | Class II |
| Classification Panel: | Orthopaedic |
Predicate Devices (with corresponding subject Device)
The subject NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System is submitted as a bundled submission. The following table lists predicate device 510(k) numbers used to demonstrate substantial equivalence. The following subject devices have been aligned with their respective predicate devices:
| S No | Subject Device | Predicate Device |
|---|---|---|
| Small Fragment | ||
| 01 | Distal Radius Volar Locking Plate, | |
| Left & Right | Synthes (USA) VOLAR DISTAL RADIUS PLATE(K953644) | |
| 02 | Small Locking Plate | Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate(K082807 |
| 03 | Distal Tibial Medial Locking Plate, | |
| Left & Right | Synthes (USA) Medial Distal Tibia Plate (K001945) | |
| 04 | Reconstruction Locking Plate | |
| 3.5mm | Synthes 4.5 mm LCP Straight Reconstruction Plate (K051986) | |
| 05 | Clavicle Medial Locking Plate, Left | |
| & Right | Synthes 3.5mm LCP Clavicle Plate System (K111540) | |
| 06 | Distal Humerus D/L @ Support | |
| LCP, Left & Right | Synthes 3.5 MM LCPDISTAL HUMERUS SYSTEM (K033995) | |
| 07 | Distal Humerus Medial LCP Plate, | |
| Left & Right | Synthes 3.5 MM LCP DISTAL HUMERUS SYSTEM (K033995) | |
| 08 | Distal Fibula VA LCP, Left and Right | Synthes 2.7mm / 3.5mm LCP Distal Fibula Plate (K073460) |
| 09 | Anterolateral Distal Tibia Locking | |
| Plate, Left & Right | Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plate | |
| (K092812) | ||
| 10 | Medial Proximal Tibia Locking | |
| Plate, Left & Right | Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plate (K032269) | |
| 11 | Posterior Medial Proximal Tibial | |
| Locking Plate | Synthes 3.5mm LCP Proximal Tibia Plates(K030597) | |
| 12 | Anatomical Proximal Tibia Locking | |
| Plate, Left and Right | SYNTHES ANATOMICAL LOCKING PLATE SYSTEM (K961413) | |
| Large Fragment | ||
| 13 | Narrow and Broad Locking Plates Ø | |
| 4.5mm | Synthes 3.5 and 4.5mm Locking Compression Plate System (K082807) | |
| 14 | Broad Locking Plate Ø 4.5mm | Synthes 3.5 and 4.5mm Locking Compression Plate System (K082807) |
| 15 | Distal Femur Locking Plate, Right & | |
| Left | Synthes LCP Distal FemurPlates (K062564) | |
| 16 | Lateral Tibia Locking Plate, Right & | |
| Left | Synthes LCP Proximal Tibia Plate (K011978) | |
| 17 | Philos Locking Plate | Synthes (USA) LCP® Proximal Humerus Plates, Long (K041860) |
| 18 | Narrow LC DCP Plate, 3.5mm | Synthes 3.5 and 4.5mm Locking Compression Plate System (K082807) |
| 19 | D.H.S. Plate 135 Degree with | |
| Dynamic Hip Screw (Non- Locking) | ||
| Long Barrel and Short Barrel D.H.S. | ||
| Plate 130 Degree with Dynamic Hip | ||
| Screw (Non- Locking) Long Barrel | ||
| and Short Barrel | Synthes Limited Contact- Dynamic Hip Screw Implant (LC-DHS) for | |
| K923613S | ||
| Synthes Titanium Limited Contact-Dynamic Hip Screw Implant | ||
| (Ti LC- DHS) for K953607 | ||
| Locking and Non-Locking Screw | ||
| 20 | D.H.S. Lag Screw | Synthes Limited Contact- Dynamic Hip Screw Implant (LC-DHS)" for |
| K923613Synthes Titanium Limited Contact-Dynamic Hip Screw Implant | ||
| (Ti LC-DHS) for K953607 | ||
| 21 | Locking Screw, Ø 2.7mm - Self | |
| Tapping | Synthes Small Fragment Dynamic CompressionLocking (DCL) System | |
| (K000684) | ||
| 22 | Locking Screw, Ø 3.5mm - Self | |
| Tapping | Synthes Small Fragment Dynamic Compression Locking (DCL) System | |
| (K000684) | ||
| 23 | Cortical Screw Ø 3.5mm 20 TPI | |
| (Self Tapping) | Synthes Cortical Screws K112583 | |
| 24 | Cannulated Cancellous Screw Ø 4.0 | |
| mm, 16mm Thread, 32mm Thread | ||
| and Full Thread | Synthes (USA) 6.5 mm Cancellous Screws (K061621) | |
| 25 | Cortical Screw Ø 4.5mm, | |
| Self-Tapping | Synthes Cortical Screws K112583 | |
| 26 | Locking Screw, Ø4.9 mm | |
| Self-Tapping | Synthes Large Fragment Dynamic Compression Locking (DCL) System | |
| (K000682) | ||
| 27 | Cancellous Screw, Ø6.5mm, 16mm | |
| Thread, 32mm Thread and Full | ||
| Thread | Synthes (USA) 6.5 mm Cancellous Screws (K061621) |
4
510(k) Summary
5
Device Description
The NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System is submitted as a bundled submission. Throughout the submission there is a mention of NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System that represents the range of products covered under this 510(k) submission. The NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are subdivided into the following categories:
| S. No. | Category | Types |
|---|---|---|
| 01 | Mini, Small and Large | Volar Plates, T-Shaped, Angled Plates, |
| Reconstruction plates | ||
| 02 | Dynamic compression | Small, Narrow, Lengthening |
| 03 | Hip Plate | Dynamic Hip Screw Plates |
| 04 | Bone Screws | Locking and Non-Locking Version |
Generally, there are the following types of bone plates used with cortical (cortex), cancellous, and Locking Screws. These bone plates are generally designed on the basis of the bone contour and anatomy.
| S. No. | Type | Subtype |
|---|---|---|
| 01 | Mini, Small and Large | |
| Fragment | Volar Plates, T-Shaped, Angled Plates, | |
| Reconstruction plates | ||
| 02 | Dynamic compression | Small, Narrow, Lengthening Narrow, Broad Plates |
| 03 | Hip Plate | Dynamic Hip Screw Plates |
NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking selftapping screws, compression and dynamic screws.
The plates and screws are fabricated from Stainless Steel and Titanium. The implants are supplied non-sterile and should be steam-sterilized prior to use.
The system contains several models based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, and the ankle. The plate implants are available in models such as Reconstruction Plates, T- Plates, , Anatomical Plates, and Clavicle Plates.
These all are mainly divided into the following:
- . Large Fragment Plates
- Small Fragment Plates
- Hip Plates (DHS Plate)
6
510(k) Summarv
The thickness of the plates varies from 1.3mm to 6mm; and the nomber of the holes varies from 2 to 20. The Locking screw implants are in corresponding diameter ranges from 2.7mm, and 4.9 mm diameters with lengths varying as per the requirements and lengths of 10mm to 90 mm
The Non-locking cortical screw implants are in 3.5mm diameter and length range from 10mm to 80mm.
The Non-locking cancellous screws are in 6.5mm diameter and length range from 30mm to 120mm The Non-locking cannulated cancellous screws are in 4.0mm diameter and length range from 10mm to 72mm
The Lag Screw is of 12.5mm Diameter and length from 50mm to 120mm
Indications for Use
NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are provided non-sterile.
NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are indicated for treating fractures of various bones including the clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).
The system is indicated for use in adult patients only. All implants are for single use only.
Comparison of Technological Characteristics
A comparison between the NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System and predicate devices has been performed which has resulted in demonstration of similarities in dimensional and performance criteria. The subject and predicate devices are similar in geometry and dimensions, intended and indicated uses, materials, sterilization methods, and performance.
Non-Clinical Performance Testing
NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are of similar design and pattern as well as similar information was not necessary to demonstrate substantial equivalence. Performance of the NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System has been demonstrated through the test parameters outlined in ASTM F-382 and ASTM F-384 to conduct Static and Dynamic Four Point Bend Testing. Torsional and Axial pullout testing was conducted on the screws per ASTM F-543.
Conclusion
From the data presented, the NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are substantially equivalent in performance for the indications and predicate devices identified.