REPROCESSED EXTERNAL FIXATION DEVICE
Device Facts
| Record ID | K051957 |
|---|---|
| Device Name | REPROCESSED EXTERNAL FIXATION DEVICE |
| Applicant | Sterilemed, Inc. |
| Product Code | KTT · Orthopedic |
| Decision Date | Sep 21, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
The Reprocessed External Fixation Device is intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.
Device Story
Reprocessed external fixation system consisting of bridge elements (rods, articulating/telescoping components) and connection elements (clamps). Device components are reprocessed from original manufacturer's systems; some components are MR safe and non-magnetic. Anchorage elements are excluded. Used by surgeons in clinical settings to construct frames for fracture stabilization, bone transport, or limb lengthening. Healthcare providers assemble the frame manually to stabilize bone segments; output is a rigid mechanical construct that maintains bone alignment during healing. Benefits include stabilization of fractures, soft tissue management, and support for complex orthopedic trauma.
Clinical Evidence
Bench testing only. No clinical data provided. Functional testing and process validation of cleaning procedures were conducted to demonstrate equivalence to original manufacturer devices.
Technological Characteristics
System includes carbon fiber rods and metallic clamps/articulating components. Some components are MR safe and non-magnetic. Modular design allows for construction of large, medium, small, and mini fixation frames. Sterilization is performed as part of the reprocessing cycle. No software or electronic components.
Indications for Use
Indicated for construction of external fixation frames for pediatric and adult patients to treat long bone, pelvic, hand, wrist, and foot fractures, including comminuted, intra-articular, open, and fracture dislocations; non-unions; tumor resections; and as an adjunct for arthrodeses, osteotomies, and indirect reduction. Contraindications include cases where stable internal fixation is possible or where soft tissue/bone conditions preclude external fixation.
Regulatory Classification
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.
Predicate Devices
- Synthes Reprocessed External Fixation Devices (K033158)
- Synthes Large External Fixation Clamps MR Safe (K031428)
- Synthes Medium External Fixation System MR Safe (K040258)
Submission Summary (Full Text)
{0}------------------------------------------------
K051957 (pg 1 of 2)
SEP 2 1 2005
# SECTION 2. SUMMARY AND CERTIFICATION
#### 2.A. 510(k) Summary
| Submitter: | SterilMed, Inc. |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Thomas A. Dold MBA, RAC<br>Director of Regulatory Affairs<br>SterilMed, Inc.<br>11400 73 <sup>rd</sup> Ave. N<br>Minneapolis, MN 55369<br>Ph: 763-488-3400<br>Fax: 763-488-3350 |
| Date Prepared: | July 18, 2005 |
| Trade Name: | Reprocessed External Fixation Device |
| Classification Name:<br>And Number: | External Fixation Device<br>Class II, 21 CFR 888.3030 |
| Product Code: | KTT |
| Predicate Device(s): | The Reprocessed External Fixation Device is substantially<br>equivalent to the Synthes Reprocessed External Fixation<br>Devices (K033158), Synthes Large External Fixation<br>Clamps MR Safe (K031428) and Synthes Medium External<br>Fixation System MR Safe (K040258). |
| Device Description: | The Reprocessed External Fixation Device consists of the<br>standard bridge elements (rods, articulating and telescoping<br>components), and connection elements (clamps) contained<br>in the original manufacturer's system. Some of the<br>components are MR safe and made of non-magnetic<br>materials. MR safe components are intended for use in the<br>MR environment. Anchorage elements are not included in<br>the Reprocessed External Fixation Device. |
| Intended Use: | The Reprocessed External Fixation Device is intended for<br>use in the construction of an external fixation frame for<br>treatment of various fracture types that require external<br>fixation. |
{1}------------------------------------------------
K051957 (pg 2 of 2)
Functional and Representative samples of Reprocessed External Fixation Safety Testing: Devices underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning procedure. In addition, the manufacturing process includes visual and functional testing of all products prior to release. The External Fixation Device reprocessed by SterilMed is Conclusion: substantially equivalent to counterpart devices originally manufactured by Synthes. This conclusion is based upon the devices' similarities in functional design, materials and indications for use.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized representation of three human figures, depicted as flowing, interconnected lines.
Public Health Service
SEP 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas A. Dold, MBA, RAC Director of Regulatory Affairs SterilMed, Inc. 11400 73td Avenue North Minneapolis, Minnesota 55369
Re: K051957 Trade/Device Name: Reprocessed External Fixation Device (See enclosed list) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: July 18, 2005 Received: July 19, 2005
Dear Mr. Dold:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication we nave reviewed your Section - 10(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate, to regars mannent date of the Medical Device Amendments, or to commerce prior to May 26, 1776, the enacified in accordance with the provisions of the Federal Food. Drug, devices that have been reclassince in accessaries while in a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval and Cosmelle Act (Act) that do not require approvisions of the general controls provisions of the Act. The You may, dicierore, market the act nelude requirements for annual registration, listing of general controls provisions of the fiel 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 If your device is classified (see abore) into Existing major regulations affecting your device can
may be subject to such additional controls. Existing major and device of D fifay be subject to such additional connounce and to 898. In addition, FDA may be found in the Overning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean I lease oc advised that I Dri 3 issualled or with other requirements of the Act that TDA has made a dolorimiation administered by other Federal agencies. You must or any receral statutes and regulations administer on registration and listing (21 Comply with an the For s requirements, and manufacturing practice requirements as sch CFN Fatt 607), labeling (21 CFR Part 800), good if applicable, the electronic forth in the quality byetems (Sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
#### Page 2- Mr. Thomas A. Dold, MBA, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin marketing your arrantial equivalence of your device to a legally premarket hourication. The PDA maing of backannal sor 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 If you desire specific advice for your ac now to the regulation entitled, and office of contact the Office of Comphanee at (210) 216 of 807.97). You may obtain ' Misolanding by reference to premation in the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or and index birds Manufacturers, internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson, M.S.
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
# Page 3– Mr. Thomas A. Dold, MBA, RAC
Reprocessed External Fixation Device Models found to be Substantially Equivalent:
| | Manufacturer # | Description |
|----------------|---------------------------------------------------------|--------------------------------------------------------|
| 1. | 390.002 | Large 6 Position Multi-Pin Clamp, MR Safe |
| 2. | 390.003 | Rod Attachment for Large Multi-Pin Clamp, MR Safe |
| 3. | 390.004 | Large 4 Position Multi-Pin Clamp, MR Safe |
| 4. | 390.005 | Large Combination Clamp, MR Safe |
| 5. | 390.006 | Dynamization Clip for Large Combination Clamp, MR Safe |
| 6. | 390.007 | Tube-to-Tube Clamp, MR Safe |
| 7. | 390.008 | Large Open Adjustable Clamp, MR Safe |
| 8. | 394.80 | 11.0mm Carbon Fiber Rod, 100mm length |
| 9. | 394.81 | 11.0mm Carbon Fiber Rod, 125mm length |
| 10. | 394.82 | 11.0mm Carbon Fiber Rod, 150mm length |
| 11. | 394.83 | 11.0mm Carbon Fiber Rod, 200mm length |
| 12. | 394.84 | 11.0mm Carbon Fiber Rod, 250mm length |
| 13. | 394.85 | 11.0mm Carbon Fiber Rod, 300mm length |
| 14. | 394.86 | 11.0mm Carbon Fiber Rod, 350mm length |
| 15. | 394.87 | 11.0mm Carbon Fiber Rod, 400mm length |
| Manufacturer # | Description | |
| 390.031 | Medium Combination Clamp, MR Safe | |
| 390.032 | Dynamization Clip for Medium Combination Clamp, MR Safe | |
| 390.033 | Medium 4 Position Multi-Pin Clamp, MR Safe | |
| 390.034 | Rod Attachment for Medium Multi-Pin Clamp, MR Safe | |
| 390.035 | Medium Open Adjustable Clamp, MR Safe | |
| 390.036 | Medium 6 Position Multi-Pin Clamp, MR Safe | |
| 390.037 | 8.0mm/11.0mm Combination Clamp, MR Safe | |
| 395.779 | 8.0mm Carbon Fiber Rod, 160mm length | |
| 395.780 | 8.0mm Carbon Fiber Rod, 180mm length | |
| 395.782 | 8.0mm Carbon Fiber Rod, 200mm length | |
| 395.784 | 8.0mm Carbon Fiber Rod, 220mm length | |
| 395.786 | 8.0mm Carbon Fiber Rod, 240mm length | |
| 395.788 | 8.0mm Carbon Fiber Rod, 280mm length | |
| 395.792 | 8.0mm Carbon Fiber Rod, 320mm length | |
| 394.796 | 8.0mm Carbon Fiber Rod, 360mm length | |
| 394.797 | 8.0mm Carbon Fiber Rod, 400mm length | |
I arge External Fixation Device Components
### Medium External Fixation Device Components
{5}------------------------------------------------
## Page 4– Mr. Thomas A. Dold, MBA, RAC
| | Manufacturer # | Description |
|-----|----------------|-----------------------------------------------------------|
| 32. | 390.041 | Small Combination Clamp, MR Safe |
| 33. | 390.051 | 4.0mm Adjustable Clamp for Distal Radius Fixator, MR Safe |
| 34. | 395.54 | 4.0mm/2.5mm Open Clamp |
| 35. | 395.55 | 4.0mm/4.0mm Open Clamp |
| 36. | 395.56 | 4.0mm/2.5mm Clamp |
| 37. | 395.57 | 4.0mm/4.0mm Clamp |
| 38. | 395.597 | 4.0mm Adjustable Clamp for Distal Radius Fixator |
| 39. | 395.60 | 4.0mm Carbon Fiber Rod, 60mm length |
| 40. | 395.61 | 4.0mm Carbon Fiber Rod, 80mm length |
| 41. | 395.62 | 4.0mm Carbon Fiber Rod, 100mm length |
| 42. | 395.63 | 4.0mm Carbon Fiber Rod, 120mm length |
| 43. | 395.64 | 4.0mm Carbon Fiber Rod, 140mm length |
| 44. | 395.65 | 4.0mm Carbon Fiber Rod, 160mm length |
| 45. | 395.66 | 4.0mm Carbon Fiber Rod, 180mm length |
| 46. | 395.67 | 4.0mm Carbon Fiber Rod, 200mm length |
:
Small External Fixation Device Components
#### Mini External Fixation Device Components
| | Manufacturer # | Description |
|-----|----------------|-------------------------------------|
| 47. | 395.105 | 3.0mm Carbon Fiber Rod, 25mm length |
| 48. | 395.107 | 3.0mm Carbon Fiber Rod, 45mm length |
| 49. | 395.109 | 3.0mm Carbon Fiber Rod, 60mm length |
| 50. | 395.111 | 3.0mm Carbon Fiber Rod, 75mm length |
| 51. | 395.125 | Mini Holding Clamp, 1.25mm |
| 52. | 395.126 | Mini Holding Clamp, 1.6mm |
| 53. | 395.133 | 3.0mm/3.0mm Connecting Clamp |
| 54. | 395.134 | 3.0mm/4.0mm Connecting Clamp |
.
{6}------------------------------------------------
### Indications for Use
(pg 1 of 2) 510(k) Number (if known):
Device Name: Reprocessed External Fixation Device
Indications for Use:
The Reprocessed External Fixation Device is intended for use in the construction of an I he Reprocessed External I mation Dollar is a learnet types that require external fixation.
#### LARGE
LAKGE
Provide treatment for long bone and pelvic fractures that require external fixation Specifically, the components are used for:
- Stabilization of soft tissues and fractures .
- Polytrauma/multiple orthopedic trauma .
- r of traumannuluipte orthopours as treatment adjunct for vertically unstable . pelvic fractures
- pervic fractures
Arthrodeses and osteotomics with soft tissue problems; failures of total joints .
- Archited of tractures stabilized with limited internal fixation ●
- Non-unions/septic non-unions .
- Intra-operative reductions/stabilization tool to assist with indirect reduction .
- I Inilateral rectilinear bone segment transport or leg lengthening .
#### MEDIUM
MEDIUM
Indicated for construction of an external fixation frame for the treatment of pediatric and adult fractures.
#### SMALL
Stabilizes and provides treatment for fractures of the small bones, such as the hand, wrist, Stabilizes and provided aspecifically, the components can be used for:
- Preliminary fixation before ORIF .
- Unstable fractures of the distal radius (both intra and extra-articular) .
- Open and/or comminuted bilateral fractures .
- Open and or combination with extensive soft tissue injury, bone loss, and vascular ● and/or neural involvement
- Fracture dislocations .
- Failed closed reduction with casting resulting in secondary deformity (radial . shortening and angulations)
- shortening and angulations)
Pediatric open fractures with bone loss and osteotom Division Sign-Off) .
Division of General, Restorative. and Neurological Devices
510(k) Notification - Reprocessed External Fixation Device July 18, 2005 SterilMed, Inc. CONFIDENTIAL
510/k) Numher K05 957 r. /:
{7}------------------------------------------------
K051957 (pg 2 of 2)
#### MINI
MINI
Stabilizes and provides treatment for fractures of the hand and foot Specifically, the components can be used for:
- Comminuted fractures of phalanges and metacarpals .
- Displaced intra-articular fractures .
- Segmental bone loss .
- Segmental other of that do not allow stable internal fixation .
- Fractures with associated complex soft tissue injuries .
- Tumor resections .
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
2
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
**510(k) Number** K051957 4.2/2
