(146 days)
Not Found
No
The device description focuses on manual instruments for surgical technique and attachment to a navigation system, with no mention of AI/ML capabilities or image processing.
No.
The device describes instruments (manual handles and aiming arms) used to facilitate the surgical technique related to various bone plate and intramedullary nail systems for fracture stabilization and repair. These instruments are tools for the surgeon, rather than a device intended to directly provide a therapeutic effect on the patient. The therapeutic effect comes from the implants, not the instruments themselves.
No
The device description indicates that the Synthes Brainlab Compatible Instruments are used to facilitate the surgical technique and manual insertion of bone plates and intramedullary nail implants. Its intended use is to stabilize fractures and treat non-unions and malunions. While it can be used with a navigation system, its primary function is surgical instrumentation for treatment, not diagnosis.
No
The device description explicitly states it consists of "manual insertion handles and aiming arms," which are physical instruments, not software. While these instruments are indicated for use with a navigation system (Brainlab Trauma Navigation System), the submitted device itself is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used to stabilize and fix bone fractures in various anatomical locations. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details manual insertion handles and aiming arms used to facilitate surgical techniques for implanting bone plates and nails. This aligns with surgical tools, not diagnostic equipment.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a surgical instrument system used in conjunction with bone implants and potentially a navigation system to aid in fracture repair.
N/A
Intended Use / Indications for Use
Synthes Lateral Entry Femoral Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions. The Synthes Lateral Entry Femoral Nail System also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System
Synthes ALPS System is a plate and screw system intended to treat fractures of various long bones including radius, ulna, humerus, tibia, fibula, and femur. The Synthes ALPS is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System
Synthes LCP System is intended for buttressing multifragmentary distal femur fracture including supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, ad non -unions and malunions. The Synthes LCP is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System.
The Synthes Curved Broad Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of per-prosthetic fractures, osteopenic bone and nonunions or malunions. The Synthes Curved Broad Plates is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System
The Synthes Curved Condylar Plates are intended for buttressing multi-fragmentary distal femur fractures, including: supracondylar, intra-articular and extra articular condylar fractures, peri-prosthetic fractures and fractures in normal or osteopenic bone, nonunions/malunions, and osteotomies of the femur. The Synthes Curved Condylar Plates is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System
Synthes LCP Distal Femur Plates are intended for buttressing multi-fragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fracture and fractures in normal osteopenic bone, non-unions and malunions, and osteotomies of the femur. The Synthes LCP Distal Femur Plate is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System.
Product codes (comma separated list FDA assigned to the subject device)
HSB, HRS, KTT
Device Description
The Synthes (USA) Brainlab Compatible Instruments consist of manual insertion handles and aiming arms which are used to facilitate the surgical technique related to the Synthes Lateral Entry Femoral Nail, LISS, LCP Distal Femur Plate, Locking Condylar Plate, and Curved Condylar Plate systems. The instruments primarily facilitate the manual insertion of the bone plate and intramedullary nail implants included in the predicate systems, but also include a design feature which allows attachment of system accessories to the Brainlab Trauma navigation system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral shaft, subtrochanteric, femoral neck/shaft, radius, ulna, humerus, tibia, fibula, femur
Indicated Patient Age Range
Not Found
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)
Dimensional tolerance analyses and simulated use studies were conducted and the results support the conclusion that there are no effects of the modification subject to this premarket notification on the safety and effectiveness of the predicate systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K040336, K961413, K000066, K041911, K062564
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
| 510(k) Summary | Page 1 of 3 |
|---|---|
| Purpose of Submission: | Is to modify the following previously cleared systems: Synthes |
| (USA) Synthes Lateral Entry Femoral Nail (K040336) Synthes | |
| LISS System (Synthes Anatomic Locking Plate System) | |
| (K961413) Synthes (USA) Locking Condylar Plate System | |
| (K000066) Synthes (USA) LCP Curved Condylar Plates | |
| (K041911) Synthes LCP Distal Femur Plates (K062564) to | |
| introduce modified instruments, which are manual accessory | |
| instruments intended to facilitate compatibility with the Brainlab | |
| Trauma Navigation System. | |
| Sponsor: | Synthes (USA) |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| (610) 719-6604 | |
| Date: | July 30, 2011 |
| Contact: | Christopher Hack, Esq. |
| Synthes (USA) | |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| (610) 719-6941 | |
| Device Name: | Synthes Brainlab Trauma Compatible Instruments |
| Classification: | Class II, §888.3020 - Intramedullary fixation rod. |
| Product Code: HSB (Rod, Fixation, Intramedullary and Accessoies). | |
| Class II, §888.3030 - Single/multiple component metallic bone | |
| fixation appliances and accessories. | |
| Product Code: HRS (Plate, Fixation, Bone). | |
| Product Code: KTT (Appliance, Fixation, Nail/Blade Combination, | |
| Multiple Component). | |
| Predicate | |
| Devices: | Synthes (USA) Synthes Lateral Entry Femoral Nail (K040336) |
| Synthes LISS System (Synthes Anatomic Locking Plate System) | |
| (K961413) | |
| Synthes (USA) Locking Condylar Plate System (K000066) | |
| Synthes (USA) LCP Curved Condylar Plates (K041911) | |
| Synthes LCP Distal Femur Plates (K062564) | |
| Device | |
| Description: | The Synthes (USA) Brainlab Compatible Instruments consist of |
| manual insertion handles and aiming arms which are used to facilitate | |
| the surgical technique related to the Synthes Lateral Entry Femoral |
CONFIDENTIAL
1
Nail, LISS, LCP Distal Femur Plate, Locking Condylar Plate, and Curved Condylar Plate systems. The instruments primarily facilitate the manual insertion of the bone plate and intramedullary nail implants included in the predicate systems, but also include a design feature which allows attachment of system accessories to the Brainlab Trauma navigation system.
Intended Use:
Synthes Lateral Entry Femoral Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions. The Synthes Lateral Entry Femoral Nail System also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System
Synthes ALPS System is a plate and screw system intended to treat fractures of various long bones including radius, ulna, humerus, tibia, fibula, and femur. The Synthes ALPS is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System
Synthes LCP System is intended for buttressing multifragmentary distal femur fracture including supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, ad non -unions and malunions. The Synthes LCP is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System.
The Synthes Curved Broad Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of per-prosthetic fractures, osteopenic bone and nonunions or malunions. The Synthes Curved Broad Plates is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System
The Synthes Curved Condylar Plates are intended for buttressing multi-fragmentary distal femur fractures, including: supracondylar, intra-articular and extra articular condylar fractures, peri-prosthetic fractures and fractures in normal or osteopenic bone, nonunions/malunions, and osteotomies of the femur. The Synthes Curved Condylar Plates is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System
Synthes LCP Distal Femur Plates are intended for buttressing multi-fragmentary distal femur fractures
CONFIDENTIAL
2
KIII891
including: supracondylar, intra-articular and extraarticular condylar, periprosthetic fracture and fractures in normal osteopenic bone, non-unions and malunions, and osteotomies of the femur. The Synthes LCP Distal Femur Plate is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System.
Substantial Equivalence:
Information presented in this premarket notification supports that there are no effects of the described modification on the safety and effectiveness of the predicate Synthes Lateral Entry Femoral Nail (K040336), Synthes Distal Femur LISS (Synthes Anatomic Locked Plating System, K961413), Synthes Locking Condylar Plate System (K000066), Synthes LCP Curved Condylar Plate System (K041911), and Synthes LCP Distal Femur Plates (K062564). The modification does not affect the predicate system's indications for use, design of intramedullary implants, fundamental technology and or implant material composition.
Dimensional tolerance analyses and simulated use studies were conducted and the results support the conclusion that there are no effects of the modification subject to this premarket notification on the safety and effectiveness of the predicate systems.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes (USA) % Mr. Christopher Hack, Esq. 1301 Goshen Parkway West Chester, PA 19380
NOV 2 8 2011
Re: K111891
Trade/Device Name: Synthes Brainlab Trauma Compatible Instruments Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HRS, KTT Dated: October 27, 2011 Received: October 31, 2011
Dear Mr. Hack:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Christopher Hack, Esq.
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Einel Keith
S/Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K111891 (pg. 1 of 5)
Device Name: Synthes (USA) Lateral Entry Femoral Nail System
INDICATIONS FOR USE:
Synthes Lateral Entry Femoral Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions. The Synthes Lateral Entry Femoral Nail System also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System
Prescription Use X (Per 21 CFR 801.109)
AND/OR
ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael Hayes to Mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
6
510(k) Number (if known): K111891 (pg.2 of 5)
Device Name:
Synthes (USA) Anatomic Locking Plate System
INDICATIONS FOR USE:
Synthes ALPS System is a plate and screw system intended to treat fractures of various long bones including radius, ulna, humerus, tibia, fibula, and femur. The Synthes ALPS is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System
Prescription Use X (Per 21 CFR 801.109) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael Owens to MXM
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111891
7
510(k) Number (if known): K111891 (pg. 3 of 5)
Device Name:
Synthes (USA) Locking Condylar Plates
INDICATIONS FOR USE:
Synthes LCP System is intended for buttressing multi-fragmentary distal femur fracture including supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and cxtractive unions and malunions. The Synthes LCP is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael Ques formym
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111891
8
510(k) Number (if known): K111891 (pg. 4 of 5)
Device Name:
Synthes (USA) LCP Curved Plates
INDICATIONS FOR USE:
The Synthes Curved Broad Plates are intended for fixation of various long bone, such as the humerus, femur, and tibia. They are also for use in fixation of per-prosthetic fractures, osteopenic bone and non-unions or malunions. The Synthes Curved Broad Plates is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma navigation system
The Synthes Curved Condylar Plates are intended for buttressing multifragmentary distal femur fractures, including: supracondylar, intraarticular and extra articular condylar fractures, peri-prosthetic fractures and fractures in normal or osteopenic bone, nonunions/malunions, and osteotomies of the femur. The Synthes Curved Condylar Plates is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| --------------------- | -- |
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number Y 1118
9
510(k) Number (if known): K111891 (pg, 5 of 5)
Device Name:
Synthes (USA) LCP Distal Femur Plate
INDICATIONS FOR USE:
Synthes LCP Distal Femur Plates are intended for buttressing multifragmentary distal femur fractures including: supracondylar, intraarticular and extra-articular condylar, periprosthetic fracture and fractures in normal osteopenic bone, non-unions and malunions, and osteotomies of the femur. The Synthes LCP Distal Femur Plate is also indicated for use with manual accessory instruments intended to be used with the Brainlab Trauma Navigation System
Prescription Use X (Per 21 CFR 801.109) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C) .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael Owens for MXM
(Division Sign-Off) Division of Surgical, Orthopedica and Restorative Devices
510(k) Number K111891