DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm

Q: Who is the manufacturer of DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm?

Synthes (USA) Products, LLC filed the 510(k) submission for DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm (K201346).

Q: What is the FDA product code for DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm?

HSB. It is classified under 21 CFR 888.3020 as a Class 2 device in the Orthopedic panel.

Q: What is the regulatory pathway for DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm?

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

Q: What are the predicate devices for DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm?

Synthes Retrograde/Antegrade Femoral Nail (K033618); Synthes 4.0 and 5.0mm Locking Screws (K000089).

Q: Who can help prepare an FDA 510(k) submission like DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm?

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.

K201346 · Synthes (USA) Products, LLC · HSB · Sep 23, 2020 · Orthopedic

Device Facts

Record ID	K201346
Device Name	DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm
Applicant	Synthes (USA) Products, LLC
Product Code	HSB · Orthopedic
Decision Date	Sep 23, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3020
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The DePuy Synthes Retrograde Femoral Nail Advanced System is intended to stabilize fractures of the distal femur and the femoral shaft, including: - Supracondylar fractures, including those with intra-articular extension - Combination of ipsilateral condylar and diaphyseal fractures - Ipsilateral femur/tibia fractures - Femoral fractures in multiple trauma patients - Periprosthetic fractures - Fractures in the morbidly obese - Fractures in osteoporotic bone - Impending pathologic fractures - Malunions and nonunions The DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm are indicated for the static and dynamic interlocking of femoral, humeral and tibial nails.

Device Story

Modular intramedullary nail system for distal femur and femoral shaft fracture stabilization. Implants feature two bend options for standard or periprosthetic entry points. Locking screws (5.0 mm) include retaining head recess and rounded cutting flutes for power driving. Used by orthopedic surgeons in clinical/OR settings. System stabilizes bone fragments to facilitate healing in complex fracture patterns, including osteoporotic or periprosthetic cases. Output is mechanical fixation of bone segments.

Clinical Evidence

No clinical data. Substantial equivalence determined via bench testing, including static/dynamic bend and torsion (ASTM F1264), mechanical static construct, screw pull-out, debris evaluation, torsional properties, driving torque, axial pushout, self-tapping performance (ASTM F543), and finite element analysis.

Technological Characteristics

Materials: titanium alloys, stainless steel, polyethylene. Design: modular intramedullary nail with two bend options; 5.0 mm locking screws with retaining head recess and rounded cutting flutes. Testing standards: ASTM F1264 (nail), ASTM F543 (screws), AAMI ST72 (endotoxin).

Indications for Use

Indicated for stabilization of distal femur and femoral shaft fractures, including supracondylar, intra-articular, condylar/diaphyseal, ipsilateral femur/tibia, multiple trauma, periprosthetic, morbidly obese, osteoporotic, impending pathologic, malunions, and nonunions. Locking screws indicated for static/dynamic interlocking of femoral, humeral, and tibial nails.

Regulatory Classification

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.

Predicate Devices

Synthes Retrograde/Antegrade Femoral Nail (K033618)
Synthes 4.0 and 5.0mm Locking Screws (K000089)

Related Devices

K253566 — Affixus Retrograde Femoral Nailing System · Zimmer, Inc. · Mar 12, 2026
K181296 — Syntec Femoral Nail System · Syntec Scientific Corporation · Apr 11, 2019
K220659 — AUTOBAHN(R) EVO Femoral Nails · Globus Medical, Inc. · Sep 9, 2022
K033618 — SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM · Synthes (Usa) · Feb 5, 2004
K072161 — BIOMET FEMORAL LOCKING NAIL SYSTEM · Biomet Manufacturing Corp · Sep 20, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ September 23, 2020 Image /page/0/Picture/1 description: The image contains 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. Synthes (USA) Products, LLC Keith Knapp RA Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380 USA Re: K201346 Trade/Device Name: DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HWC Dated: August 20, 2020 Received: August 24, 2020 ## Dear Keith Knapp: 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. 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 {1}------------------------------------------------ 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, For Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201346 Device Name DePuy Synthes Retrograde Femoral Nail Advanced System DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm Indications for Use (Describe) The DePuy Synthes Retrograde Femoral Nail Advanced System is intended to stabilize fractures of the distal femur and the femoral shaft, including: - Supracondylar fractures, including those with intra-articular extension - Combination of ipsilateral condylar and diaphyseal fractures - Ipsilateral femur/tibia fractures - Femoral fractures in multiple trauma patients - Periprosthetic fractures - Fractures in the morbidly obese - Fractures in osteoporotic bone - Impending pathologic fractures - Malunions and nonunions The DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm are indicated for the static and dynamic interlocking of femoral, humeral and tibial nails. 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo consists of a circular symbol with three rings, followed by the company name in blue, and the tagline "People inspired" in a cursive font. The text "part of the Johnson & Johnson family of companies" is written in a smaller font below the company name. #### 5. F 510(k) Summary | Sponsor | DePuy Synthes Keith Knapp 1301 Goshen Parkway West Chester, PA 19380 Phone: +1-610-719-5942 | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared | May 19, 2020 | | Proprietary Name | DePuy Synthes Retrograde Femoral Nail Advanced System DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm | | Device Common Name | Rod, Fixation, Intramedullary And Accessories Screw, Fixation, Bone | | Classification Name | Intramedullary fixation rod. Smooth or threaded metallic bone fixation fastener. | | Classification | Class II Regulation Number: 21 CFR 888.3020 & 888.3040 Product Code: HSB, HWC | | Predicate Devices | Primary Predicate Devices: Synthes Retrograde/Antegrade Femoral Nail (K033618) Secondary Predicate Devices: Synthes 4.0 and 5.0mm Locking Screws (K000089) | | Device Description | The proposed Retrograde Femoral Nail Advanced System is being developed to address challenges associated with treating distal femur fractures with intramedullary nails. The system is modular in nature, incorporating several components to allow for the treatment of a variety of fracture patterns and in the presence of previously implanted devices such as the femoral components of a total knee arthroplasty (periprosthetic). The nailing implants are available in two different bends which enable standard and periprosthetic entry points for the insertion of the nailing implant in the femur. The implants in this submission are manufactured from titanium alloys, stainless steel and polyethylene and are provided in a range of dimensions. The DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm feature a retaining screw head recess, additional shorter, rounded cutting flutes the ability to drive under power. The screws feature either a standard screw head or a low-profile screw head and are available with standard washers and nuts. | | | The Retrograde Femoral Nail Advanced System is indicated to stabilize fractures of the distal femur and femoral shaft, including: | | Indications for use | - Supracondylar fractures, including those with intraarticular extension - Combination of ipsilateral condylar and diaphyseal fractures - Ipsilateral femur/tibia fractures - Femoral fractures in multiple trauma patients - Periprosthetic fractures - Fractures in the morbidly obese - Fractures in osteoporotic bone - Impending pathologic fractures - Malunions and non-unions | | | The DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm are indicated for the static and dynamic interlocking of femoral, humeral and tibial nails. | | Non-clinical Performance Data | The following analyses were conducted for the Retrograde Femoral Nail Advanced System • Static Bend according to ASTM F1264 • Static Torsion according to ASTM F1264 • Dynamic Bend according to ASTM F1264 • Mechanical Static Construct • Poly Inlay Screw Pull Out Test and Debris Evaluation The following analyses were conducted for the DePuy Synthes Locking Screws for Medullary Nails, 5.0 • Torsional Properties according to ASTM F543 • Driving Torque & Axial Pushout according to ASTM F543 • Driving Torque according to ASTM F543 • Self-tapping Performance according to ASTM F543 • Finite Element Analysis for 3-Point Bending according to ASTM 1264 Other Additional Analysis: • Endotoxin Testing was performed according to AAMI ST72 • MRI Conditional analysis has been performed to establish MR Conditional parameters for the subject implants however DePuy Synthes is choosing not to release these devices with MR Conditional labeling at this time | | Clinical Performance Data | Clinical testing was not necessary for the determination of substantial equivalence. | | Substantial Equivalence | The proposed subject devices have the same intended uses as the predicate devices. The proposed subject devices share similar or the same indications, are similar in design, material, and fundamental technology with the identified predicate devices. | | | | | The testing and analytical evaluation included in this submission demonstrate that: • Any differences in technological characteristics of the predicate devices do not raise any new questions of safety and effectiveness The proposed devices are at least as safe and effective as the predicate devices | | | In conclusion, the results of non-clinical performance data demonstrate that | | | the subject device is substantially equivalent with the predicate devices. | | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a circular symbol with intersecting lines, followed by the text "DePuy Synthes" in a bold, dark blue font. To the right of the company name, the words "People inspired" are written in a cursive, light-colored font. The text "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" is written in a smaller font below the company name. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo consists of a circular symbol to the left of the company name, which is written in a dark blue font. To the right of the company name, the phrase "People inspired" is written in a cursive font. The text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" is written in a smaller font below the company name.