Medline ReNewal Reprocessed Stryker External Fixation Devices

K163028 · Surgical Instrument Service and Savings, Inc. · JEC · Dec 28, 2016 · Orthopedic

Device Facts

• Record ID: K163028
• Device Name: Medline ReNewal Reprocessed Stryker External Fixation Devices
• Applicant: Surgical Instrument Service and Savings, Inc.
• Product Code: JEC · Orthopedic
• Decision Date: Dec 28, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medline ReNewal Reprocessed Stryker External Fixation Devices are components in an external fixation system that is used to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts or other means of fixation.

Device Story

Reprocessed external fixation components (rods, couplings, connectors, clamps, posts) for use with Stryker Hoffmann external fixation systems. Devices are assembled external to the operative site; no direct patient contact. Used by surgeons in clinical settings to provide temporary skeletal stabilization for fractures, osteotomies, or deformity corrections. Reprocessing restores used OEM devices to original functional specifications through cleaning and structural integrity testing. Benefits include providing stable fixation in complex trauma cases where internal fixation is contraindicated.

Clinical Evidence

Bench testing only. No clinical data. Performance evaluated via functional studies including simulated use, artificial soiling, structural integrity, carbon rod stiffness (4-point bend test, pre/post-conditioning), cyclical axial compression/tension, and disassembly/reassembly post-sterilization. Cleaning efficacy validated via residual protein and carbohydrate analysis.

Technological Characteristics

External fixation frame components including rods, couplings, connectors, clamps, and posts. Materials include stainless steel and carbon fiber. Devices are modular, designed for assembly into skeletal constructs. Reprocessed to restore original OEM specifications. No electronic or software components.

Indications for Use

Indicated for patients requiring stabilization of open/unstable fractures, osteotomy, arthrodesis, deformity correction, revision procedures, or bone reconstruction where other treatments (IM rods, casts) are precluded. Compatible with Hoffmann 3 MR Conditional, Hoffmann II MR Conditional, Hoffmann II, Hoffmann II Compact MR Conditional, and Hoffmann II Compact systems.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Stryker Hoffman II External Fixation System Line Extension (K102885)

Reference Devices

• Howmedica Hoffmann II External Fixation System (K952730)
• Stryker Hoffmann 3 Modular External Fixation System (K122284)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles suggesting a sense of community and support. The profiles are rendered in a dark color, creating a strong contrast against the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 28, 2016

Surgical Instrument Service and Savings Inc. Brandi J. Panteleon Director, Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756

Re: K163028

Trade/Device Name: Medline ReNewal Reprocessed Stryker External Fixation Devices Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JEC Dated: October 28, 2016 Received: October 31, 2016

Dear Brandi Panteleon:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

## Caroline Rhim -S

for

Mark Melkerson Division Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure: Reprocessed List

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| Part Number | Description | | |
|-------------|----------------------------------------------------------------|-------------------------------------------|--------------------------------------------|
| 4920-1-010 | Rod to Rod Coupling for 8mm rods or posts | | |
| 4920-1-020 | Pin to Rod Coupling for 4-5mm pins/8mm rods or posts | | |
| 4920-1-030 | Inverted Pin to Rod Coupling for 8mm rods or posts/4-5mm pins | | |
| 4920-1-100 | Tube to Rod Coupling for 20mm tubes/8mm rods or posts | | |
| 4920-2-020 | 5 Hole Pin Clamp for 4/5/6mm pins | | |
| 4920-2-060 | 10-Hole Pin Clamp for 4/5/6mm pins | | |
| 4920-2-080 | Pelvic Clamp for 4/5/6mm pins | | |
| 4920-2-120 | Straight Post 8mm | | |
| 4920-2-140 | 30° Angled Post 8mm | | |
| 4920-2-160 | 90° Angled Post 8mm | | |
| 4920-2-181 | HII THREADED POST W 13mm NUT | | |
| 4920-9-020 | Removable Thumbwheel | | |
| 4940-1-010 | Rod to Rod Coupling for Ø5mm rods or posts | | |
| 4940-1-015 | HII Compact Baltimore Coupling | | |
| 4940-1-020 | Pin to Rod Coupling- Ø5mm rods or posts/Ø3-4mm pins | | |
| 4940-1-058 | Rod to Rod Coupling-Ø8mm rods, posts/Ø5mm rods, posts | | |
| 4940-1-100 | Tube to Rod Coupling - Ø15mm tube/Ø5mm rods or posts | | |
| 4940-2-020 | Hoffmann 2 Compact Pin Clamp 4 hole Pin Clamp-Ø3 and Ø4mm pins | | |
| 4940-2-120 | Straight Post Ø5mm | | |
| 4940-2-140 | 30° Angled Post Ø5mm | | |
| 4940-2-200 | Peri-Articular Pin Clamp for Ø3mm pins | | |
| 4960-1-010 | Micro Rod to Rod Coupling 3mm/3mm | | |
| 4960-1-020 | Micro Pin to Rod Coupling 1.65mm-2mm/3mm | | |
| 4960-1-060 | Micro Rod to Rod Coupling 5mm/3mm | | |
| 4960-2-020 | Micro Multi-Pin Clamp | | |
| 4960-2-030 | 90° Micro Multi-Pin Clamp | | |
| 4960-3-020 | HII Micro Lengthener Pin Clamp | | |
| 4960-3-030 | HII Micro Lengthener Thumbwheel | | |
| 5029-1-611 | Ball Joint 5 Hole Double Parallel | | |
| 5029-8-805 | Carbon Connecting Rod 8mm x 65mm | | |
| 5029-8-810 | Carbon Connecting Rod 8mm x 100mm | | |
| 5029-8-815 | Carbon Connecting Rod 8mm x 150mm | | |
| 5029-8-820 | Carbon Connecting Rod 8mm x 200mm | | |
| 5029-8-825 | Carbon Connecting Rod 8mm x 250mm | | |
| 5029-8-830 | Carbon Connecting Rod 8mm x 300mm | | |
| 5029-8-835 | Carbon Connecting Rod 8mm x 350mm | | |
| 5029-8-840 | Carbon Connecting Rod 8mm x 400mm | | |
| 5029-8-845 | Carbon Connecting Rod 8mm x 450mm | | |
| 5029-8-850 | Carbon Connecting Rod 8mm x 500mm | | |
| 5049-5-065 | Stainless Steel Connecting Rod Ø5mm x 65mm | | |
| 5049-5-100 | Stainless Steel Connecting Rod Ø5mm x 100mm | | |
| 5049-5-150 | Stainless Steel Connecting Rod Ø5mm x 150mm | | |
| 5049-5-200 | Stainless Steel Connecting Rod Ø5mm x 200mm | | |
| 5049-5-250 | Stainless Steel Connecting Rod Ø5mm x 250mm | | |
| 5049-5-300 | Stainless Steel Connecting Rod Ø5mm x 300mm | | |
| 5049-5-505 | Carbon Connecting Rod Ø5mm x 65mm | | |
| 5049-5-510 | Carbon Connecting Rod Ø5mm x 100mm | | |
| 5049-5-515 | Carbon Connecting Rod Ø5mm x 150mm | | |
| 5049-5-520 | Carbon Connecting Rod Ø5mm x 200mm | | |
| 5049-5-525 | Carbon Connecting Rod Ø5mm x 250mm | | |
| 5049-5-530 | Carbon Connecting Rod Ø5mm x 300mm | | |
| 5049-7-018 | Semi Circular Curved Rod-Stainless Steel Ø5mm x 111mm | | |
| 5049-7-020 | Semi Circular Curved Rod-Stainless Steel Ø5mm x 146mm | | |
| 5079-5-030 | Stainless Steel Connecting Rod 3mm x 30mm | | |
| 5079-5-040 | Stainless Steel Connecting Rod 3mm x 40mm | | |
| 5079-5-050 | Stainless Steel Connecting Rod 3mm x 50mm | | |
| 5079-5-060 | Stainless Steel Connecting Rod 3mm x 600mm | | |
| 5079-5-070 | Connecting Rod 3mm x 70mm | | |
| 5079-5-090 | 5079-5-120 | Stainless Steel Connecting Rod 3mm x 90mm | Stainless Steel Connecting Rod 3mm x 120mm |
| 5079-5-150 | Stainless Steel Connecting Rod 3mm x 150mm | | |
| 5079-5-180 | Connecting Rod 3mm x 180mm | | |
| 5079-5-250 | Connecting Rod 3mm x 250mm | | |
| 5079-5-300 | Connecting Rod 3mm x 300mm | | |
| 5079-6-030 | Carbon Connecting Rod 3mm x 30mm | | |
| 5079-6-040 | Carbon Connecting Rod 3mm x 40mm | | |
| 5079-6-050 | Carbon Connecting Rod 3mm x 50mm | | |
| 5079-6-060 | Carbon Connecting Rod 3mm x 60mm | | |
| 5079-6-090 | Carbon Connecting Rod 3mm x 90mm | | |
| 5079-6-120 | Carbon Connecting Rod 3mm x 120mm | | |
| 5079-6-150 | Carbon Connecting Rod 3mm x 150mm | | |

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| Part Number | Description |
|-------------------------------------|------------------------------------------------------------------------------------------------|
| 4921-1-010 | MR conditional 8mm Rods or Posts, Rod to Rod Coupling (Gold Hardware) |
| 4921-1-020 | MR conditional Pin to Rod Coupling for Ø4-5mm pins/Ø8mm rods or posts (Gold Hardware) |
| 4921-1-030 | MR conditional Inverted Pin to Rod Coupling for Ø8mm rods or posts/Ø4-5mm pins (Gold Hardware) |
| 4921-1-100 | MR conditional Tube to Rod Coupling for Ø20mm tubes/Ø8mm rods or posts (Gold Hardware) |
| 4921-2-020 | MR conditional 5-Hole Pin Clamp for Ø4, Ø5, and Ø6mm pins (Gold Hardware) |
| 4921-2-060 | MR conditional 10-Hole Pin Clamp for Ø4, Ø5, and Ø6mm pins (Gold Hardware) |
| 4921-2-080 | MR conditional Pelvic Clamp for Ø4, Ø5, and Ø6mm pins (Gold Hardware) |
| 4921-2-120 | MR conditional Straight Post Ø8mm (Gold Tip) |
| 4921-2-140 | MR conditional 30° Angled Post Ø8mm (Gold Tip) |
| 4941-1-010 | MR conditional rod to Rod Coupling for Ø5mm rods or posts |
| 4941-1-020 | MR conditional Pin to Rod Coupling for Ø5mm rods or posts/Ø3-4mm pins |
| 4941-1-058 | MR conditional Rod to Rod Coupling for Ø8mm rods or posts/Ø5mm rods or posts |
| 4941-1-100 | MR conditional Tube to Rod Coupling for Ø15mm tube/Ø5mm rods or posts |
| 4941-2-120 | MR conditional 30° Angled Post Ø5mm |
| 4941-2-140 | MR conditional 4941-2-140 30° Angled Post Ø5mm |
| 4941-2-200 | MR conditional Peri-Articular Pin Clamp for Ø3mm pins |
| 5028-7-030 | MR conditional Semi-Circular Carbon Rod 174mm (L) |
| 5028-8-065 | MR conditional Carbon Connecting Rod 65mm Ø8mm (Yellow) |
| 5028-8-100 | MR conditional Carbon Connecting Rod 100mm Ø8mm (Yellow) |
| 5028-8-150 | MR conditional Carbon Connecting Rod 150mm Ø8mm (Yellow) |
| 5028-8-200 | MR conditional Carbon Connecting Rod 200mm Ø8mm (Yellow) |
| 5028-8-250 | MR conditional Carbon Connecting Rod 250mm Ø8mm (Yellow) |
| 5028-8-300 | MR conditional Carbon Connecting Rod 300mm Ø8mm (Yellow) |
| 5028-8-350 | MR conditional Carbon Connecting Rod 350mm Ø8mm (Yellow) |
| 5028-8-400 | MR conditional Carbon Connecting Rod 400mm Ø8mm (Yellow) |
| 5028-8-450 | MR conditional Carbon Connecting Rod 450mm Ø8mm (Yellow) |
| 5028-8-500 | MR conditional Carbon Connecting Rod 500mm Ø8mm (Yellow) |
| 5048-5-065 | MR conditional Carbon Connecting Rod 65mm Ø5mm (Yellow) |
| 5048-5-100 | MR conditional Carbon Connecting Rod 100mm Ø5mm (Yellow) |
| 5048-5-150 | MR conditional Carbon Connecting Rod 150mm Ø5mm (Yellow) |
| 5048-5-200 | MR conditional Carbon Connecting Rod 200mm Ø5mm (Yellow) |
| 5048-5-250 | MR conditional Carbon Connecting Rod 250mm Ø5mm (Yellow) |
| 5048-5-300 | MR conditional Carbon Connecting Rod 300mm Ø5mm (Yellow) |
| 4921-2-020 | AHS MR conditional 5 HOLE PIN CLAMP |
| 4921-2-160 | MR conditional 90 DEGREE POST |
| 4941-2-020 | 4 hole pin clamp for Ø3 and Ø4mm pins |
| Hoffmann III MR Conditional (1.5 T) | |
| Part Number | Description |
| 4922-1-010 | Delta Coupling, Rod-to-Rod or Pin-to-Rod, Ø5/8/11mm Rods and Ø5mm Apex Pins |
| 4922-1-020 | Delta Coupling, Pin-to-Rod, Ø5/8/11mm Rods and Ø4/5/6mm Apex Pins |
| 4922-1-030 | Delta Coupling, Pin-to-Rod, inverted, Ø5/8/11mm Rods and Ø4/5/6mm Apex Pins |
| 4922-2-020 | 5-Hole Pin Clamp |
| 4922-2-120 | Straight Post Ø11mm |
| 4922-2-140 | 30° Angled Post Ø11mm |
| 4922-2-160 | 90° Angled Post Ø11mm |
| 4922-2-220 | 5-Hole Pin Clamp with two Ø11mm Straight Posts |
| 4922-2-240 | 5-Hole Pin Clamp with two Ø11mm 30° Angled Posts |
| 4922-2-320 | 5-Hole Pin Clamp with one Ø11mm Straight Post |
| 4922-2-340 | 5-Hole Pin Clamp with one Ø11mm 30° Angled Post |
| 4922-8-100 | Ø11mm Vectran coated Carbon Connecting Rods 100mm |
| 4922-8-150 | Ø11mm Vectran coated Carbon Connecting Rods 150mm |
| 4922-8-200 | Ø11mm Vectran coated Carbon Connecting Rods 200mm |
| 4922-8-250 | Ø11mm Vectran coated Carbon Connecting Rods 250mm |
| 4922-8-300 | Ø11mm Vectran coated Carbon Connecting Rods 300mm |
| 4922-8-350 | Ø11mm Vectran coated Carbon Connecting Rods 350mm |
| 4922-8-400 | Ø11mm Vectran coated Carbon Connecting Rods 400mm |
| 4922-8-450 | Ø11mm Vectran coated Carbon Connecting Rods 450mm |
| 4922-8-500 | Ø11mm Vectran coated Carbon Connecting Rods 500mm |
| 4922-8-550 | Ø11mm Vectran coated Carbon Connecting Rods 550mm |
| 4922-8-600 | Ø11mm Vectran coated Carbon Connecting Rods 600mm |
| 4922-8-650 | Ø11mm Vectran coated Carbon Connecting Rods 650mm |

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## Indications for Use

#### Device Name

Medline ReNewal Reprocessed Stryker External Fixation Devices

### Indications for Use (Describe)

The Medline ReNewal Reprocessed Stryker External Fixation Devices are external fixation frame components for use with components of the Hoffmann 3 MR Conditional. Hoffmann II MR Conditional. Hoffmann II Compact MR Conditional and Hoffmann II Compact external fixation systems. They are intended to provide stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts or other mean of internal fixations for use of external fixation devices include:

- · bone fracture fixation;
- · osteotomy:
- · arthrodesis:
- · correction of deformity; revision procedure where other treatments or devices have been unsuccessful; and
- · bone reconstruction procedures.

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)

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Image /page/6/Picture/1 description: The image shows the logo for Medline Renewal. The Medline logo is on the left, and it features the word "MEDLINE" in blue, with a blue star-like symbol below it. To the right of the Medline logo is the word "Renewal" in large, bold letters, with "Re" in green and "newal" in blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller, lighter font.

# 510(k) Summary K163028

| Submitter/<br>Owner | Surgical Instrument Service and Saving Inc. dba Medline ReNewal<br>2747 SW 6th St.<br>Redmond, OR 97756 | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Contact Name | Brandi Panteleon<br>Director, Quality Assurance and Regulatory Affairs<br>P: 541-516-4180<br>F: 541-923-3375<br>E: [e-mail] | |
| Prepared by | Stephanie Boyle Mays<br>Regulatory Affairs Specialist, Regulatory Affairs<br>P: 541-516-4205<br>F: 541-923-3375<br>E:[e-mail] | |
| Date Prepared | October 28, 2016 | |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Stryker External<br>Fixation Devices<br>Common Name: External Fixation Devices, Fixation Appliance,<br>single/multiple component (component) | |
| Classification | Classification: Class II<br>Classification Name: Single/multiple component metallic bone fixation<br>appliances and accessories and smooth or threaded metallic bone fixation<br>fastener.<br>Regulation Number/Product Code: 888.3030/JEC (subsequent code LXT);<br>888.3040/JEC; and 888.3030/KTT | |
| Predicate<br>Device | K102885 Stryker Hoffman II External Fixation System Line Extension Model<br>4920-1-010, 4920-1-020; 4920-1-030, 4920-1-100, Hoffmann II EX | |
| Reference<br>Device 1 | K952730 Howmedica Hoffmann II External Fixation System | |
| Reference<br>Device 2 | K122284 Stryker Hoffmann 3 Modular External Fixation System | |
| Device<br>Description | The Medline ReNewal Reprocessed Stryker External Fixation Devices are<br>intended to provide temporary stabilization of open and/or unstable<br>fractures where soft tissue injury may preclude the use of other fracture<br>treatments. Additionally, the devices may be used for elective orthopedic<br>interventions such as limb lengthening. Devices in the scope of this<br>document include various rods and clamps/connectors that are assembled<br>external to the operative or injury focus and will not be in direct patient<br>contact. | |
| Statement of<br>Intended Use | The Medline ReNewal Reprocessed Stryker External Fixation Devices are<br>components in an external fixation system that is used to provide<br>stabilization of open and/or unstable fractures and where soft tissue injury<br>may preclude the use of other fracture treatments such as IM rods, casts or<br>other means of fixation. | |
| Indications | The Medline ReNewal Reprocessed Stryker External Fixation Devices are external fixation frame components for use with components of the Hoffman 3 MR Conditional, Hoffmann II MR Conditional, Hoffmann II, Hoffmann II Compact MR Conditional and Hoffmann II Compact external fixation systems. They are intended to provide stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts or other mean of internal fixation The indications for use of external fixation devices include:<br>• bone fracture fixation;<br>• osteotomy;<br>• arthrodesis;<br>• correction of deformity; revision procedure where other treatments or devices have been unsuccessful; and<br>• bone reconstruction procedures. | |
| Technological<br>Characteristics | The Medline ReNewal Reprocessed Stryker External Fixation Devices are rods, couplings, connectors, clamps, posts and accessories that, when combined with other components, are used to build external skeletal constructs for the devices intended use. The proposed device is a reprocessed version of the predicate device and the technological characteristics of these devices are substantially equivalent. | |
| Performance<br>Testing | The functional characteristics of the subject device have been evaluated and have been determined to be substantially equivalent to the predicate device based on the following tests:<br>• Functional performance studies:<br>◦ simulated use and artificial soiling; and<br>◦ structural integrity;<br>◦ carbon rod stiffness per the 4-point bend test (pre-conditioning);<br>◦ cyclical axial compression and tension bending test;<br>◦ carbon rod stiffness per the 4-point bend test (post conditioning); and<br>◦ disassembly and reassembly (pre-and post-sterilization).<br>• Cleaning:<br>◦ visual inspection;<br>◦ cleaning efficacy (residual protein and residual carbohydrate). | |
| | OEM<br>Model | Description |
| | Hoffmann II | |
| Device Models | 4920-1-010 | Rod to Rod Coupling for 8mm rods or posts |
| | 4920-1-020 | Pin to Rod Coupling for 4-5mm pins/8mm rods or posts |
| | 4920-1-030 | Inverted Pin to Rod Coupling for 8mm rods or posts/4-5mm pins |
| | 4920-1-100 | Tube to Rod Coupling for 20mm tubes/8mm rods or posts |
| | 4920-2-020 | 5 Hole Pin Clamp for 4/5/6mm pins |
| | 4920-2-060 | 10-Hole Pin Clamp for 4/5/6mm pins |
| | 4920-2-080 | Pelvic Clamp for 4/5/6mm pins |
| | 4920-2-120 | Straight Post 8mm |
| | 4920-2-140 | 30° Angled Post 8mm |
| OEM<br>Model | Description | |
| Hoffman II continued | | |
| 4920-2-181 | HII THREADED POST W 13mm NUT | |
| 4920-9-020 | Removable Thumbwheel | |
| 4940-1-010 | Rod to Rod Coupling for Ø5mm rods or posts | |
| 4940-1-015 | HII Compact Baltimore Coupling | |
| 4940-1-020 | Pin to Rod Coupling- Ø5mm rods or posts/Ø3-4mm pins | |
| 4940-1-058 | Rod to Rod Coupling-Ø8mm rods, posts/Ø5mm rods, posts | |
| 4940-1-100 | Tube to Rod Coupling - Ø15mm tube/Ø5mm rods or posts | |
| 4940-2-020 | Hoffmann 2 Compact Pin Clamp 4 hole Pin Clamp-Ø3 and<br>Ø4mm pins | |
| 4940-2-120 | Straight Post Ø5mm | |
| 4940-2-140 | 30° Angled Post Ø5mm | |
| 4940-2-200 | Peri-Articular Pin Clamp for Ø3mm pins | |
| 4960-1-010 | Micro Rod to Rod Coupling 3mm/3mm | |
| 4960-1-020 | Micro Pin to Rod Coupling 1.65mm-2mm/3mm | |
| 4960-1-060 | Micro Rod to Rod Coupling 5mm/3mm | |
| 4960-2-020 | Micro Multi-Pin Clamp | |
| 4960-2-030 | 90° Micro Multi-Pin Clamp | |
| 4960-3-020 | HII Micro Lengthener Pin Clamp | |
| 4960-3-030 | HII Micro Lengthener Thumbwheel | |
| 5029-1-611 | Ball Joint 5 Hole Double Parallel | |
| 5029-8-805 | Carbon Connecting Rod 8mm x 65mm | |
| 5029-8-810 | Carbon Connecting Rod 8mm x 100mm | |
| 5029-8-815 | Carbon Connecting Rod 8mm x 150mm | |
| 5029-8-820 | Carbon Connecting Rod 8mm x 200mm | |
| 5029-8-825 | Carbon Connecting Rod 8mm x 250mm | |
| 5029-8-830 | Carbon Connecting Rod 8mm x 300mm | |
| 5029-8-835 | Carbon Connecting Rod 8mm x 350mm | |
| 5029-8-840 | Carbon Connecting Rod 8mm x 400mm | |
| 5029-8-845 | Carbon Connecting Rod 8mm x 450mm | |
| 5029-8-850 | Carbon Connecting Rod 8mm x 500mm | |
| 5049-5-065 | Stainless Steel Connecting Rod Ø5mm x 65mm | |
| 5049-5-100 | Stainless Steel Connecting Rod Ø5mm x 100mm…