OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE

K133809 · Oxford Performance Materials · KKY · Jul 28, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K133809
• Device Name: OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE
• Applicant: Oxford Performance Materials
• Product Code: KKY · General, Plastic Surgery
• Decision Date: Jul 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OsteoFab® Patient Specific Facial Device (OPSFD) is designed individually for each patient for enhancement, to correct trauma, and/or to correct defects in facial bone. The OPSFD is also designed individually for non-load bearing enhancement of mandibular bone.

Device Story

The OsteoFab® Patient Specific Facial Device (OPSFD) is a patient-specific, non-load bearing implant manufactured from polyetherketone (PEKK) polymer using laser sintering technology. The device is custom-designed for each patient based on their CT imaging data and computer-aided design (CAD) to match specific facial bone geometry. It is intended for use in facial bone enhancement, trauma correction, or defect repair. The device is shipped non-sterile and is intended for permanent implantation, attached to native bone using commercially available fixation systems. It is operated by surgeons in a clinical setting. The device provides a structural form for reconstruction; it does not impart mechanical strength to the implant area. Clinical benefit is derived from the patient-specific fit, which aids in the restoration of facial anatomy.

Clinical Evidence

Bench testing only. Testing included tensile strength (ASTM D638), axial pullout force (ASTM F543-07), drop characterization, and dimensional stability after multiple steam sterilization cycles. Biocompatibility was verified per ISO 10993-3, 5, 6, 10, 11, and 18. Endotoxin levels were tested per USP 85. No clinical data was provided.

Technological Characteristics

Material: PEKK polymer. Manufacturing: Laser sintering. Dimensions: 1-10 mm thickness, max 20 cm diameter. Fixation: Plate and screw systems. Sterilization: Gravity displacement or prevacuum steam sterilization (ANSI/AAMI ST79). Connectivity: None. Software: CAD-based design process.

Indications for Use

Indicated for patients requiring enhancement, trauma correction, or defect repair of facial bone, including non-load bearing enhancement of mandibular bone.

Regulatory Classification

Identification

A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.

Predicate Devices

• Polyclinic Medical Center Hard Tissue Replacement (HTR) Patient Matched Implant (K924935)
• Synthes SynPOR HD Porous Polyethylene (K111323)
• Stryker® Patient Specific Polymer Implant (K103010)

Reference Devices

• OsteoFab® Patient Specific Cranial Device (OPSCD) (K121818)

Submission Summary (Full Text)

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# 5 - OPSFD 510(k) Summary Statement as Required by Title 21 CFR 807.92(c)

510(k) Submitter: Oxford Performance Materials, Inc. P.O. Box 585 30 South Satellite Road South Windsor, CT 06074 1-860-698-9300

Contact Person: Leigh Ayres, Director of Scientific and Regulatory Affairs Date of 510(k) summary statement preparation: July 21, 2014 Proprietary name: OsteoFab® Patient Specific Facial Device Common or Usual Name: Polytetrafluoroethylene (PTFE) with Carbon Fibers Classification: 878.3500 General/Plastic Surgery Review Panel: General/Plastic Surgery Medical Device Classification: Class II Product Code: KKY Predicate Devices: Polyclinic Medical Center Hard Tissue Replacement (HTR) Patient Matched Implant (K924935), the Synthes SynPOR HD Porous Polyethylene (K111323), and the Stryker® Patient Specific Polymer Implant (K103010)

#### Description of the Device

An OsteoFab® Patient Specific Facial Device (OPSFD) is built individually for each patient. The OPSFD is made of polyetherketone (PEKK) polymer and built by a LASER sintering machine. The OPSFD is constructed with the use of the patient's CT imaging data and computer aided design to determine the dimensions of each implant. OPSFDs come in a variety of configurations that depend on the geometry of the application. OPSFDs are oblong and (for an individual patient) have shapes and sizes that vary within the following specifications: (1) maximum diameter is 20 cm (2) minimum thickness is 1 mm, (3) maximum thickness is 10 mm, (4) maximum open density is 25%, (5) minimum as built hole diameter is 3 mm, (6) maximum as built hole diameter is 5 mm, and (6) minimum distance from the edge of an as built hole to the edge of a device is 15 mm.

The OPSFD is attached to native bone with commercially available fixation systems and it is a permanent implant. The OPSFD is a non-load bearing single use device and it does not impart mechanical strength to the implant area. The OPSFD implant is shipped non-sterile and the sterilization recommendations documented in the instructions for use (IFU) are according to ANSI/AAMI ST79 "Comprehensive Guide to Steam Sterility Assurance in Health Care Facilities" have been validation for gravity displacement steam sterilization

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was conducted at 135°C (275°F) with a half cycle of five (5) minutes. The validation for prevacuum steam sterilization was conducted at 132°C (270°F) with a half cycle of two (2) minutes.

#### Intended Use Statement

The OsteoFab® Patient Specific Facial Device (OPSFD) is designed individually for each patient for enhancement, to correct trauma, and/or to correct defects in facial bone. The OPSFD is also designed individually for non-load bearing enhancement of mandibular bone.

#### Biocompatibility

Biocompatibility tests were selected according to the FDA guidance document: "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (1995) and the test results obtained from PEKK test specimens were found to be within acceptance criteria described in the ISO 10993-3, 5, 6, 10, 11, and 18 standards.

The results of cytotoxicity testing on OsteoFab® test specimens utilizing L-929 mouse fibroblast cells or human neuroblastoma SK-N-MC cells were within ISO 10993-5 acceptance criteria.

The Limulus Amebocyte Lysate method was performed on OsteoFab® test specimens to evaluate bacterial endotoxin utilizing the Gel-Clot method according to USP 85. The test results were below the medical device contacting cerebral spinal fluid acceptance criterion (<2.15 EU/Device).

#### Performance Testing - Bench Testing

#### QUALITY CONTROL

The test suite for the final quality control (QC) testing of the OsteoFab® Patient Specific Facial Device (OPSFD) builds includes glass transition temperature (Tg), Fourier transform infrared spectroscopy (FTIR), specific gravity, and tensile strength. This is the same QC testing that is performed when an OsteoFab® Patient Specific Cranial Device (OPSCD) is manufactured. The OPSCD device was cleared by the FDA on February 7, 2013 (K121818).

The final QC specifications for those tests were determined from 32 builds. TABLE 18.A shows the mean, the standard deviation, the standard deviation multiplied by 3, the acceptance criteria, and the formula for the acceptance criteria.

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| | Tg<br>(20°C/min) | FTIR | Average<br>Specific<br>Gravity | Average<br>Tensile<br>Stress at<br>Break (X-<br>orientation)<br>(KPSI) | Average<br>Tensile<br>Elongation<br>@ Break<br>(%) | Average<br>Young's<br>Modulus of<br>Elasticity<br>(KPSI) |
|----------------------------------------------|------------------|-------------------------------------------------------|--------------------------------|------------------------------------------------------------------------|----------------------------------------------------|----------------------------------------------------------|
| mean | 158.16 | 98.11 | 1.29 | 11.67 | 2.63 | 509.09 |
| SDEV | 0.51 | 1.16 | 0.0072 | 0.89 | 0.39 | 75.93 |
| 3SD | 1.53 | 3.48 | 0.022 | 2.67 | 1.17 | 227.79 |
| Acceptance<br>Criteria | 157-160 | ≥ 95%<br>Match | 1.27-1.31 | ≥ 9.0 | ≥ 1.5 | ≥ 281 |
| Formula for<br>the<br>Acceptance<br>Criteria | Mean +/-<br>3SD | ≥ 95%<br>Match to a<br>designated<br>PEKK<br>standard | Mean +/-<br>3SD | Mean - 3SD | Mean - 3SD | Mean - 3SD |

#### TABLE 18.A: Summary Statistics of 32 Builds

The test specimens from the 32 builds that were subjected to tensile strength testing were 3.2 mm thick.

#### WALL THICKNESS AND THROUGH HOLE SIZE

In order to determine the minimum wall thickness for an OPSFD implant, three sets (5 specimens each) of tensile bars that were 1, 2, and 4 mm thick were built. The average tensile strength data for each size is compared to the final QC release acceptance criteria (see TABLE 18.B).

All three sizes (1, 2, and 4 mm) of test specimens are substantially equivalent to the 3.2 mm final QC test specimen because the data obtained was within the final QC acceptance criteria (see TABLE 18.B). Based on the measurements obtained, the minimum allowable thickness of an OPSFD implant is 1 mm.

| Sample Description | Average Tensile Stress at<br>Break (X-orientation)<br>(KPSI) | Average<br>Tensile<br>Elongation @<br>break<br>(%) | Average Young's<br>Modulus of<br>Elasticity (KPSI) |
|------------------------------------------|--------------------------------------------------------------|----------------------------------------------------|----------------------------------------------------|
| 1 mm thickness (average) | 10.5 | 2.4 | 329 |
| 2 mm thickness (average) | 10.8 | 2.4 | 409 |
| 4 mm thickness (average) | 11.6 | 2.4 | 490 |
| Release Criteria for 3.2 mm<br>thickness | ≥ 9.00 | ≥ 1.5 | ≥ 281 |

#### TABLE 18.B: Summary Statistics of the 1, 2, and 4 mm Thick Test Specimens

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The tensile testing was conducted according to ASTM D638 "Standard Test Method for Tensile Properties of Plastics."

Test specimens were also built to determine the range of pore (through holes) sizes and the minimum spacing of through holes. These test specimens were 4 mm thick and each had more than 10 through holes. Based on the measurements obtained, the range of through holes that can be built with the P-800 is 2 mm to 5 mm and the minimum spacing of through holes is 2 mm. TABLE 18.C and TABLE 18.D show the average of the through hole size measurements and the average of the spacing between through hole measurements, respectively.

| | TABLE 18.C: Vernier Caliper Measurements of the Diameter of Through Holes |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| In The Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Child | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>contraction of the consistence of the consistence and the consistent of the first of the support of the first of the first of the first of the first of the first of the first |

| | 5 mm Through Hole Test<br>Specimen with 5 mm Spacing<br>(Diameter in mm) | 2 mm Through Hole Test<br>Specimen with 2 mm Spacing<br>(Diameter in mm) |
|------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Average (n=10) | 4.74 | 1.92 |
| Standard Deviation | 0.03 | 0.05 |
| Nominal Value with Tolerance | 5.00 (4.50 - 5.50) | 2.00 (1.50 - 2.50) |

TABLE 18.D: Vernier Caliper Measurements of the Spacing between Through Holes

| | 5 mm Through Hole Test<br>Specimen with 5 mm Spacing<br>(Spacing in mm) | 2 mm Through Hole Test<br>Specimen with 2 mm Spacing<br>(Spacing in mm) |
|------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Average (n=10) | 4.81 | 1.79 |
| Standard Deviation | 0.02 | 0.03 |
| Nominal Value with Tolerance | 5.00 (4.50 – 5.50) | 2.00 (1.50 - 2.50) |

#### SCREW INSERTION

There were two experiments conducted to evaluate the effect of applying screws to PEKK test blocks: manually apply self-drilling screws and manually apply self-tapping screws after drilling a pilot hole.

The PEKK test blocks were 3 mm thick and had a straight edge or an edge that had a 45° angle. Each test block had 14 fingers. The PEKK test blocks were made from a build that had the job number 2634. After drilling, the screws and plates were removed and the PEKK test blocks were inspected with a 10x magnification eye loop.

Each screw (1.5 mm diameter x 4 mm) was driven into first a Thinflap plate and second into a finger of the test block. The distance between the edge of the PEKK test block and the tangent of the screw nearest to the edge was 3 mm.

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The results of the self-drilling experiment were as follows:

- 1. Fractures for the straight edge were 0/28.
- 2. Fractures for the 45° angle edge were 2/28.

The results for the self-tapping experiment were as follows:

- 3. Fractures for the straight edge were 0/28.
- 4. Fractures for the 45° angle edge were 0/28.

# DROP CHARACTERIZATION

(The test specimens utilized for this study were not from the steam sterilization validation evaluation of the IFU recommendations.)

There were three experiments conducted to evaluate the effect of dropping PEKK test specimens from four feet above the floor. The PEKK test specimens were in a cranial flap configuration (job number 2724). The PEKK test specimens were dropped horizontally in the dome up position, horizontally in the dome down position, and vertically.

The test specimens N=1 for each experiment were first steam sterilized at 134°C for 4 minutes and then dried for 30 minutes. The material loss from all three experiments was equal to or less than 0.020%. The results from the three experiments are summarized on TABLE 18.K.

| TABLE 18.K: Drop Test Results | | | |
|-------------------------------|------------------------|-----------------------------------------------------------------|----------------------------------------------|
| SEQ | Experiment Description | Percent Difference (loss) in<br>Test Specimen Weight<br>(grams) | Results of 10x Inspection |
| 1. | Horizontal, dome up | $0.017/84.036 * 100 =$<br>0.020% | Slight indentation on the<br>point of impact |
| 2. | Horizontal, dome down | $0.002/84.736 * 100 =$<br>0.002% | Slight indentation on the<br>point of impact |
| 3. | Vertical | $0.007/84.418 * 100 =$<br>0.008% | Slight indentation on the<br>point of impact |

#### EDGE DISTANCE

(The test specimens utilized for this study were not from the steam sterilization validation evaluation of the IFU recommendations.)

There were four experiments conducted to evaluate the effect of applying screws to PEKK test blocks. The experimental conditions, inspections, and the results of the inspections for each of the four experiments are shown on TABLE 18.L.

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There were 45/45 fingers in the PEKK test blocks (job 2843) in the Rev B evaluation that did not have cracks.

There were 45/45 fingers in the PEKK test blocks (job 2849) in the Rev D evaluation that did not have cracks.

Each experiment utilized PEKK test blocks (each had fourteen fingers).

| TABLE 18.1: LT1274 Summary of Experimental Conditions and Test Results | | | | |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| SEQ | Rev A: Test<br>Sequence/Results | Rev B: Test<br>Sequence/Results | Rev C: Test<br>Sequence/Results | Rev D: Test<br>Sequence/Results |
| 1. | Inspect 10x<br>magnification: pass | Inspect 10x<br>magnification: pass | Inspect 10x<br>magnification: pass | Inspect 10x<br>magnification: pass |
| 2. | Three PEKK job 2820<br>Test Blocks 3 mm<br>thick, 45° edge | Four PEKK job 2843<br>Test Blocks 3 mm<br>thick, 45° edge | One PEKK job 2849<br>Test Blocks 3 mm<br>thick, 45° edge | Four PEKK job 2849<br>Test Blocks 3 mm<br>thick, 45° edge |
| 3. | 132°C (4 min) dry<br>(30 min) x 1 | 132°C (4 min) dry<br>(30 min) x 1 | 132°C (4 min) dry<br>(30 min) x 1 | 132°C (4 min) dry<br>(30 min) x 1 |
| 4. | Inspect 10x<br>magnification: pass | Inspect 10x<br>magnification: pass | Inspect 10x<br>magnification: pass | Inspect 10x<br>magnification: pass |
| 5. | Pre-drill 1.1 mm<br>Drill with 5 mm stop<br>at 3.75 mm (Screw<br>Centerline to Edge)<br>x 45 | Pre-drill 1.1 mm<br>Drill with 5 mm stop<br>at 5 mm (Screw<br>Centerline to Edge)<br>x 45 | No pre-drilling | No pre-drilling |
| 6. | Overlay 2-hole 1.5<br>thin plate | Overlay 2-hole 1.5<br>thin plate | Overlay 2-hole 1.5<br>thin plate | Overlay 2-hole 1.5<br>thin plate |
| 7. | Manually add 1.65<br>mm diameter x 5<br>mm High Torque<br>Screws and do not<br>strip out | Manually add 1.65<br>mm diameter x 5<br>mm High Torque<br>Screws and do not<br>strip out | Manually add 1.5<br>mm diameter x 4<br>mm High Torque<br>Screws and do not<br>strip out at 5 mm<br>(Screw Centerline to<br>Edge) x 45 | Manually add 1.5<br>mm diameter x 4<br>mm High Torque<br>Screws and do not<br>strip out at 7 mm<br>(Screw Centerline to<br>Edge) x 45 |
| 8. | Remove screws | Remove screws | Remove screws | Remove screws |
| 9. | Results of 10x<br>magnification<br>Inspection: 4/45<br>cracked | Results of 10x<br>magnification<br>Inspection: 45/45<br>no cracks | Results of 10x<br>magnification<br>Inspection: 1/6<br>cracked - the study<br>was discontinued | Results of 10x<br>magnification<br>Inspection: 45/45<br>no cracks |

TABLE 18.L: LT1274 Summary of Experimental Conditions and Test Results

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## MODIFICATION

# (The test specimens utilized for this study were not from the steam sterilization validation evaluation of the IFU recommendations.)

There were three experiments conducted to evaluate the effect of modifying PEKK test specimens. The PEKK test specimens were in a cranial flap configuration (job number 2823).

The first experiment evaluated edge modification utilizing a power tool and a diamond burr or a deep flute burr. Each burring method was applied with light pressure and heavy pressure.

The second experiment evaluated re-contouring utilizing a power tool and a diamond burr or a deep flute burr. Each re-contouring method was applied with light pressure and heavy pressure.

The third experiment evaluated cutting with a power tool and a sagittal saw or a reciprocating saw.

The test specimens N=2 for each experiment were first steam sterilized at 134°C for 4 minutes and then dried for 30 minutes.

The results from the three experiments are summarized on TABLE 18.M.

| SEQ | Experiment<br>Description | Characteristic Measured | Characteristic Measured |
|-----|---------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 1. | Edge<br>Modification | Diamond burr light pressure:<br>No issues were observed with<br>both test specimens. | Diamond burr heavy pressure:<br>The debris material surrounding<br>the cut melted due to friction for<br>both test specimens. |
| 2. | Edge<br>Modification | Deep flute light pressure:<br>No problems were observed with<br>both test specimens. | Deep flute heavy pressure:<br>The deep flute burr head was<br>unstable for both test<br>specimens. |
| 3. | Re-contouring | Diamond burr light pressure:<br>The burr cut the surface very<br>well with both test specimens. | Diamond burr heavy pressure:<br>The debris material surrounding<br>the cut melted due to friction for<br>both test specimens. |
| 4. | Re-contouring | Deep flute light pressure:<br>No problems were observed with<br>both test specimens. | Deep flute heavy pressure:<br>The deep flute burr head was<br>unstable for both test<br>specimens. |

#### TABLE 18.M: Test Results from Modifying PEKK Test Specimens

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| SEQ | Experiment<br>Description | Characteristic Measured | Characteristic Measured |
|-----|---------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| 5. | Cutting | Sagittal saw: Edge cutting was<br>easy for both test specimens.<br>Surface cutting was not as easy<br>for both test specimens. | Reciprocating saw: Edge and<br>surface cutting was easy for both<br>test specimens. |

#### DIMENSIONAL STABILITY

(The test specimens utilized for this study were not from the steam sterilization validation evaluation of the IFU recommendations.)

Ten test specimens in a cranial flap configuration were subjected to three steam sterilization cycles. The part numbers were IG2823M-8F001 to IG2823M-8F010. All ten test specimens were steam sterilized at 134°C for 4 minutes. All ten test specimens were scanned with a Romer arm prior to sterilization.

After each sterilization cycle, the ten test specimens were cooled for 30 minutes prior to dimensional analysis by a Romer arm scanner. An eye loop that had a 10x magnification was utilized to inspect all 10 test specimens after each sterilization cycle.

The following results were obtained:

- 1. After each of the three sterilization cycles and for each test specimen, 99% or more of the datum points collected during the Romer arm scans were within ± 0.005 inches of the datum points collected from the pre-sterilization Romer arm scans.
- 2. No cracking, fracturing, swelling, or shrinkage was observed in any of the test specimens.

Ten test specimens in a cranial flap configuration were subjected to nine steam sterilization cycles. The part numbers were IG2823M-8F001 to IG2823M-8F010. The first three steam sterilization cycles were conducted at 134°C for 4-8 minutes. The second three steam sterilization cycles were conducted at 134°C for 4 minutes. The third three steam sterilization cycles were conducted at 137℃ for 18 minutes.

A Romer arm was utilized to scan all ten test specimens before and after nine sterilization cvcles. An eye loop that had a 10x magnification was utilized to inspect all 10 test specimens after the ninth sterilization cycle.

The following results were obtained:

- 3. After the ninth sterilization cycle, 99% or more of the datum points collected by the Romer arm from each of the ten test specimens were within ± 0.005 inches of the presterilization Romer arm datum points.
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- 4. No cracking, fracturing, swelling, or shrinkage was observed in the test specimens after nine sterilization cycles.
#### AXIAL PULLOUT FORCE AND PREDICATE COMPARISONS

(The test specimens utilized for this study were not from the steam sterilization validation evaluation of the IFU recommendations.)

There were four experiments conducted to evaluate axial pullout force. The first and the fourth experiments included the evaluation of materials that are utilized for the manufacture of predicate devices.

For the first experiment, PEKK test specimens were steam sterilized once at 134°C for four minutes and dried for 30 minutes and the PMMA test specimens were gamma sterilized once between 26.2 and 31.9 kilo Grays.

For the second experiment, PEKK test specimens were steam sterilized at 134°C for four minutes and dried for 30 minutes. All 12 test specimens were sterilized once. Eight test specimens were sterilized twice and four test specimens were sterilized three times. Repeat sterilizations were conducted to evaluate the stability of the PEKK test specimens.

For the third experiment, PEKK test specimens were steam sterilized at 137°C for 18 minutes and dried for 30 minutes. All 12 test specimens were sterilized once. Eight test specimens were sterilized twice and four test specimens were sterilized three times. Repeat sterilizations were conducted to evaluate the stability of the PEKK test specimens.

For the fourth experiment, ten PEEK test specimens were steam sterilized once at 134°C for four minutes and dried for 30 minutes.

After sterilization, each of the four experiments had all test specimens pre-drilled in two locations utilizing a 1.1 mm diameter drill that had a 5 mm stop. After pre-drilling, 1.5 mm diameter x 3.5 mm screws were manually driven into each combination of screw grip fixture and the pre-drilled through holes on each test specimen.

Each of the four experiments were conducted according to ASTM F543-07, "Standard Specification and Test Method for Metallic Medical Bone Screws, Annex A3: Test Method for determining the Axial Pullout Strength of Medical Bone Screws." The results are shown on TABLE 18.N.

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| SE<br>Q | Test<br>Specimen/Report<br>Number | N (Sample<br>Size) | Mean Peak<br>Axial<br>Pullout<br>Force<br>(Newtons) | Standard<br>Deviation | Coefficient<br>of<br>Variation<br>(%) | Sterilization<br>method/<br>Number of<br>cycles |
|---------|-----------------------------------|--------------------|-----------------------------------------------------|-----------------------|---------------------------------------|-------------------------------------------------|
| 1. | PMMA/LT1294 | 20 | 43.5 | 16.2 | 37 | Gamma x 1 |
| 2. | PEKK/LT1294 | 10 | 244.0 | 32.1 | 14 | Steam x 1 |
| 3. | PEKK/LT1294 | 10 | 227.1 | 28.0 | 12 | Steam x 1 |
| 4. | PEKK/LT1295 Rev A | 8 | 233.1 | 11.0 | 5 | Steam x 1 |
| 5. | PEKK/LT1295 Rev A | 8 | 233.1 | 23.6 | 10 | Steam x 2 |
| 6. | PEKK/LT1295 Rev A | 8 | 207.5 | 27.9 | 13 | Steam x 3 |
| 7. | PEKK/LT1295 Rev B | 8 | 196.2 | 68.1 | 35 | Steam x 1 |
| 8. | PEKK/LT1295 Rev B | 8 | 222.0 | 55.2 | 25 | Steam x 2 |
| 9. | PEKK/LT1295 Rev B | 8 | 226.4 | 73.8 | 33 | Steam x 3 |
| 10. | PEEK/LT1296 | 20 | 193.6 | 27.5 | 14 | Steam x 1 |

TABLE 18.N: Summary from the LT1294, LT1295, and LT1296 Evaluations of PMMA (Poly(methy) methacrylate), PEKK (polyetherketone) and PEEK (polyetheretherketone) Test Specimens

All test specimens had the same failure mode "the screw pulled out of material" at the peak axial pullout force. PEKK test specimens were stronger than the PMMA test specimens and the PEEK test specimens.

#### TENSILE STRENGTH PEKK DATA VERSUS A PMMA STANDARD

A comparison table of tensile strength was prepared in order to assess substantial equivalence between the (1) subject device OPSFD manufactured from OsteoFab® and (2) predicate devices made from PMMA. TABLE 18.0 shows the acceptance criteria for tensile strength derived from QC data obtained from OsteoFab® test specimens that represent the subject device (see also TABLE 18.A). TABLE 18.O also shows tensile strength values published in the ASTM D4802 document "Standard Specification for PMMA."

| Characteristic Measured | Acceptance Criteria for<br>OPSFD Calculated from N=32<br>Test Specimens | Nominal values obtained from<br>PMMA test specimens according to<br>ASTM D4802 |
|-------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Tensile at Break | ASTM D638<br>QMSP-1067 (OPSFD)<br>$\geq$ 9,000 psi | ASTM D638<br>9,000 psi |
| Elongation at Break | ASTM D638<br>QMSP-1067 (OPSFD)<br>$\geq$ 1.5 % | ASTM D638<br>2% |

TABLE 18.0: Comparison Table of Tensile Strength

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The PEKK and PMMA materials, based on tensile strength, are substantially equivalent because:

- 1. The PMMA and PEKK test specimens were prepared and tested according to ASTM D638 "Standard Test Method for Tensile Properties of Plastics."
- 2. The PMMA nominal value for tensile at break is the same value as the QC acceptance criterion for OsteoFab® test specimens.
- 3. The 2% elongation at break for PMMA is within the acceptance criterion for OsteoFab® test specimens.

#### Substantial Equivalence Discussion

The OsteoFab® Patient Specific Facial Device (OPSFD) is substantially equivalent in safety and effectiveness to three other predicate devices cleared by the FDA under Title 21 CFR 878.3500 polytetrafluoroethylene with carbon fibers composite implant material. Those three predicate devices are: the Polyclinic Medical Center Hard Tissue Replacement (HTR) Patient Matched Implant (K924935), the Synthes SynPOR HD Porous Polyethylene (K111323), and the Stryker® Patient Specific Polymer Implant (K103010). Information about the predicate devices was obtained from 510(k) summary statements and/or the 510(k) FDA Access Database.

The intended use statement for the OPSFD is within the scope of the intended use statements for the Synthes and Stryker® devices. The intended use statements encompass enhancement, to correct trauma, and/or to correct defects in the in mandibular, maxillofacial, or craniofacial bone. The intended use statement for the Polyclinic Medical Center HTR Patient Matched Implant was not available in the sources described above.

All three devices are fabricated from polymers. The OPSFD and Stryker® Patient Specific Polymer Implant are custom manufactured using patient CT data. The sources described above did not include information about the manufacturing processes for Synthes SynPOR or Polyclinic Medical Center HTR.

The sources described above did not include information about biocompatibility evaluations for the predicates. The test results obtained from OPSFD test specimens were found to be within ISO 10993-3, 5, 6, 10, 11, and 18 acceptance criteria and the endotoxin values obtained were below the medical device contacting cerebral spinal fluid acceptance criterion (<2.15 EU/Device).

The OPSFD is not porous. The Synthes and Stryker® implant devices are described as porous.

The OPSFD is shipped non-sterile in packaging that is ISTA 2A compliant. The OPSFD instructions for use describe validated steam sterilization procedures. The Synthes and Stryker® devices are shipped as sterile medical devices. Sterile packaging validation was listed for the Synthes predicate.

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The substantial equivalence information on the subject and predicate devices is summarized on the substantial equivalence chart. The substantial equivalence chart shows that the characteristics listed for the subject (OPSFD) and the three predicate devices are substantially equivalent.

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K133809 13 of 14

Substantial Equivalence Chart: Information about the predicate devices was obtained from 510(k) summary statements and/or the 510(k) FDA Access Database

| Characteristic | Subject Device<br>(OPSFD) | Stryker® Patient Specific<br>Polymer Implant<br>(K103010) | Synthes<br>SynPOR HD Porous<br>Polyethylene<br>(K111323) | Polyclinic Medical Center Hard<br>Tissue Replacement (HTR)<br>Patient Matched<br>Implant<br>(K924935) |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Manufacturer | Oxford Performance Materials | Stryker® Howmedica Osteonics | J&J DePuy Synthes | Biomet Microfixation |
| Regulation<br>Number | 878.3500 General/Plastic<br>Surgery | 878.3500 General/Plastic<br>Surgery | 878.3500 General/Plastic<br>Surgery | 878.3500 General/Plastic<br>Surgery |
| Regulation<br>Name | Polytetrafluoroethylene (PTFE)<br>with Carbon Fibers | Polytetrafluoroethylene (PTFE)<br>with Carbon Fibers | Polytetrafluoroethylene (PTFE)<br>with Carbon Fibers | Polytetrafluoroethylene (PTFE)<br>with Carbon Fibers |
| Classification | Class II | Class II | Class II | Class II |
| Product Code | KKY | KKY | KKY | KKY |
| Intended Use | The OsteoFab® Patient Specific<br>Facial Device (OPSFD) is<br>designed individually for each<br>patient for enhancement, to<br>correct trauma, and/or to<br>correct defects in facial bone.<br>The OPSFD is also designed<br>individually for non-load bearing<br>enhancement of mandibular<br>bone. | Is designed individually for each<br>patient to correct trauma<br>and/or defects in mandibular,<br>maxillofacial, or craniofacial<br>bone | The augmentation or<br>reconstruction of the<br>craniomaxillofacial skeleton.<br>Specific indications (SynPOR HD<br>Ocular Spheres):<br>* Occular reconstruction<br>* Socket preservation<br>Specific indications (SynPOR HD<br>Facial Shapes):<br>* Enhancement of the malar<br>and chin<br>* Correction of deficiencies of<br>the malar and chin | Information not provided |
| Materials | OXPEKK® Polymer | Simplex P Bone Cement<br>(PMMA) | Porous High Density<br>Polyethylene (HDPE) | PMMA |

Section 5 - OP5FD 510(k) Summary Statement 2014Jul21-2 Page 13 of 14

Oxford Performance Materials

am land of the Royal (1) 160 11 154 11 11 850 698 9900 11 41 860 698 9976 1 www.commen

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#### K133809 14 of 14

| Characteristic | Subject Device<br>(OPSFD) | Stryker® Patient Specific<br>Polymer Implant<br>(K103010) | Synthes<br>SynPOR HD Porous<br>Polyethylene<br>(K111323) | Polyclinic Medical Center Hard<br>Tissue Replacement (HTR)<br>Patient Matched<br>Implant<br>(K924935) |
|-------------------------------|------------------------------------------------------|-----------------------------------------------------------|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Dimensional<br>Specifications | Custom sized to each patient<br>using CT data | Custom sized to each patient<br>using CT data | Information not provided | Information not provided |
| Biocompatibility | ISO 10993-3, 5, 6, 10, 11, and 18<br>compliant | Information not provided | Information not provided | Information not provided |
| Endotoxin | USP 85 & AAMI ST72:<br><2.15 EU/device (CSF contact) | AAMI ST72 LAL | Information not provided | Information not provided |
| Porous | No | Yes | Yes | Information not provided |
| Fixation | Plate and screw systems | Plate and screw systems | Information not provided | Information not provided |
| Curing Required | No | Yes | Information not provided | Information not provided |
| Sterilization | Non-sterile | Sterilized by gamma radiation | Sterilized, method not provided | Information not provided |
| Packaging<br>Validation | ISTA 2A compliant | Sterile packaging validation | Information not provided | Information not provided |

#### Section 5 - OPSFD 510(k) Summary Statement 2014Jul21-2 Page 14 of 14

Oxford Performance Materials

Oxford Performance Materials
1971 – 1981 – 1988 – 1994 – 1991 – 1962 – 1941 – 1960 – 1992 – 1992 – 1992 – 1980 – 1980 – 1980 – 1980 – 1990 – 1990 – 1990 – 199

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Image /page/14/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure. The figure is composed of three curved lines that suggest a person reaching out or embracing something.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 28, 2014

Oxford Performance Materials Incorporated Ms. Leigh Ayres Director of Scientific Regulatory Affairs P.O. Box 585 30 South Satellite Road South Windsor, Connecticut 06074

Re: K133809

Trade/Device Name: OsteoFab™ Patient Specific Facial Device Regulation Number: 21 CFR 878.3500 Regulation Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: Class II Product Code: KKY Dated: June 26, 2014 Received: June 30, 2014

Dear Ms. Ayres:

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 finay or subject to additions, 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 that I Dri has made a word regulations administered by other Federal agencies. You must or any I coloni surates and regisments, including, but not limited to: registration and listing (21

{15}------------------------------------------------

Page 2 - Ms. Leigh Ayres

CFR Part 807): labeling (21 CFR Part 801); medical device reporting of medical device-related 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.

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/ResourcesforYowIndustry/default.htm. 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 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 yours,

# David 和Ause -S

- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Image /page/16/Picture/0 description: The image shows a logo or emblem that appears to spell out the letters "OPMI" in a stylized, geometric design. Each letter is constructed using a combination of squares, circles, triangles, and lines. The "O" is enclosed in a diamond shape, the "P" is a semi-circle, the "M" is a triangle on top of a rectangle, and the "I" is made of vertical lines.

#### 4 - OPSFD Indications for Use Statement

510(k) Number (if known): K133809

Device Name: OsteoFab™ Patient Specific Facial Device

Indications for Use:

The OsteoFab™ Patient Specific Facial Device (OPSFD) is designed individually for each patient for enhancement, to correct trauma, and/or to correct defects in facial bone. The OPSFD is also designed individually for non-load bearing enhancement of mandibular bone.

AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 29 CFR 801 Subpart D)

Over-The-Counter Use (29 CFR 801 Subpart C)

# (Please do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/16/Picture/10 description: The image shows the name "Peter L. Hudson -S" in a bold, sans-serif font. The text is black against a white background. The letters are clearly legible, and the overall impression is clean and professional.

Section 4 - OPSFD Indications For Use 2014Jun12 Page 1 of 1

Oxford Parformance Materials

Oxford Portormance Motorials
30 South Sciellite Rood • South Windsor, CT 06074 USA • T: +1.860.698.9978 • www.akbridpm.com