SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP

K053105 · Synthes (Usa) · HSB · Dec 2, 2005 · Orthopedic

Device Facts

• Record ID: K053105
• Device Name: SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP
• Applicant: Synthes (Usa)
• Product Code: HSB · Orthopedic
• Decision Date: Dec 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.

Device Story

Synthes Elastic Intramedullary Nail (EIN) End Cap is a titanium accessory for the EIN system; designed for insertion over the external portion of the nail. The cap is threaded into cancellous bone in an oblique orientation; features self-tapping threads with reverse cutting flutes for removal. The blunt back end minimizes soft tissue irritation. Used by surgeons in clinical settings for orthopedic fracture fixation. The device provides secure end-capping of the intramedullary nail, facilitating stable fixation while allowing for easier removal due to the self-tapping design.

Clinical Evidence

No clinical data provided; substantial equivalence based on comparative information.

Technological Characteristics

Titanium construction; self-tapping threads with reverse cutting flutes; blunt back end design; intended for use with the Synthes Elastic Intramedullary Nail (EIN) System.

Indications for Use

Indicated for fixation of diaphyseal, metaphyseal, and epiphyseal fractures in upper extremities (all patients) and lower extremities (pediatric/small-stature patients), and fixation of small long bones (carpal/tarsal). Used where canal is narrow or implant flexibility is required; allows insertion avoiding pediatric growth plates.

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

• Encore Orthopedics (formerly Applied Osteo Systems) True/Flex® Intramedullary Rod Endcaps
• Encore Orthopedics (formerly Applied Osteo Systems) True/Flex® Humerus Cap

Submission Summary (Full Text)

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DEC 2 2005

. . . . . . . . . . . . . . . . . . . .

and the contract and the consisted to the consisted to the contract

A SYNTHES ...

the control control control concession in the consideration

Andrew and the count

Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string starts with the letter 'K', followed by the numbers '053105'. The numbers are written in a cursive style, and the overall appearance suggests that it is a code or identifier. The handwriting is clear and legible, with a consistent stroke weight.

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| 3.0 | 510(k) Summary | Page 1 of 1 |
|-----|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sponsor: | Synthes (USA)<br>1302 Wrights Lane East<br>West Chester, PA 19380<br>[phone] |
| | Device Name: | Synthes Elastic Intramedullary Nail (EIN) End Cap |
| | Classification: | 21 CFR 888.3020: Intramedullary fixation rod (HSB) |
| | Predicate Devices: | Encore Orthopedics (formerly Applied Osteo Systems):<br>True/Flex® Intramedullary Rod Endcaps<br>True/Flex® Humerus Cap |
| | Device Description: | The Synthes Elastic Intramedullary Nail (EIN) End Cap is used<br>with the Synthes Elastic Intramedullary Nail (EIN) System. The<br>Titanium Elastic Nail End Cap is inserted over the external portion<br>of the nail and threaded into the cancellous bone in an oblique<br>orientation. The threads are self-tapping with reverse cutting flutes<br>to facilitate end cap removal. The back end of the cap is blunt to<br>minimize soft tissue irritation. |
| | Intended Use: | The Synthes Elastic Intramedullary Nail (EIN) System is indicated<br>for fixation of diaphyseal fractures where the canal is narrow or<br>flexibility of the implant is paramount. This includes upper<br>extremity fractures in all patients and lower extremity fractures in<br>pediatric or small-stature patients. This system is also intended to<br>treat metaphyseal and epiphyseal fractures, such as radial neck<br>fractures and is intended for fixation of small long bones, such as<br>carpal and tarsal bones. In pediatric applications, the flexibility of<br>the EIN allows it to be inserted at a point which avoids disruption<br>to the bone growth plate. |
| | Substantial<br>Equivalence: | Comparative information presented supports substantial<br>equivalence. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2005

Lisa M. Boyle Regulatory Specialist Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K053105

K053105
Trade/Device Name: Synthes (USA) Elastic Intramedullary Nail (EIN) End Cup
Trade/Device Name: Synthes 200 2000 Trauc/Device incher: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: November 2, 2005 Received: November 4, 2005

Dear Ms. Boyle:

We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Section 5 IU(K) premaince in the mindent (for the indications
referenced above and have determined the device is substantially equivalent in interstate referenced above and have deemined the usedicate devices marketed in interstate
for use stated in the enclosure) to legally marketed previce Amendments, for use stated in the enclosure) to legally market production in the Medical Device Amendments, or to
commerce prior to May 28, 1976, the ensectived the provision of the Fede commerce prior to May 28, 1976, the enactinent une of the Federal Food, Drug, devices that have been reclassified in accordance when oversions of the more of the Act.
and Cosmetic Act (Act) that do not require approval of a proval application of the Ac and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The Act. The Act. The Act. The Act. The Act. The Act. The Act. The You may, therefore, market the device, subject to the general vonmul registration, listing of
general controls provisions of the Act the lines and recisibitions and general controls provisions of the Act Include requirements as and more of the stations and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mile entirer cass if opedial som alleoting your device can
may be subject to such additional controls. Existing major regulations af may be subject to such additional controis: Listing iniger togato 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In add be found in the Code of Federal Regulations, This 24, 2017, 11:45, 11, 1991, 1991, 1991, 1991, 1991, 1991, 199

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substance on the requirements of the Act
that FDA has made a determination that your device complies with other requirements. You that FDA has made a determination intributions administered by other Federal agencies. You must
or any Federal statutes and regulations and regulation registration and list or any Federal statutes and regulations administed to registration and listing (21
comply with all the Act's requirements, including, but not ice reguirements as set comply with all the Act s requirements, including to the chiming practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); and 120); and 120); and if annicable, CFR Part 807); labeling (21 CFR Part 801); god manufacture, platfielde, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1050 forth in the quality systems (QS) regulation (21 CFR Part of Schools) =
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Lisa M. Boyle

This letter will allow you to begin marketing your device as described in your Section 510(k)
This and the submit and one of exhatential equivalence of your device to a legal This letter will allow you to begin market it equivalence of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo premarket notification. The FDA finding of substantal equivalence of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r (1) (1) (1) (1) (1) (1) (110) (110) (140) 276 (110) . Also, please note If you desire specific advice for your device on our laborating the regulation entitled,
contact the Office of Compliance at [phone]. Also, please not 91). You may contact the Office of Compliance at [phone]. Proved 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtai "Misbranding by reference to prematical international " (2) Cr Cr Cr Are Division of Small
other general information on your responsibilities under (800) 638-204 other general information on your responsionities uncer and except and one of 2001 of 2001 of 2001 of 2001 of 2001 of 2001 Manufacturers, International and Consumer Assistance at los of the March (1) 10 million (1) 10 mil.

Sincerely yours,

Mark N. Melkerson

Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

| 2.0 | Indications for Use |
|-----|---------------------|
|-----|---------------------|

| 510(k) Number (if known): | K053105 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes (USA) Elastic Intramedullary Nail (EIN) End Cap |
| Indications for Use: | The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate. |

X Prescription Use __ (Per 21 CFR 801.109)

ﻳ

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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ー・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Gff) Division of General, Restorative, and Neurological Devices

510(k) Number_KOS 3 |05