Transforaminal Posterior Atraumatic Lumbar Interbody Cage System

T-PAL™ Interbody System

Advanced Applicator

Addendum to Surgical Technique

T-PAL™ Interbody System Addendum to Surgical Technique DePuy Synthes 1

Product Overview

IntroductionThe T-PAL Advanced Applicator has a reduced profile compared to the Standard Applicator (see Figures 1 and 2) and is designed to allow for flexibility in the angle of approach and to facilitate release of the implant from the applicator following final placement.

The T-PAL Advanced Applicator is designed to work with the existing T-PAL Trial Implants (03.812.307–317 and 03.812.507–517) and Implants (08.812.007S–017S, 08.812.207S–217S, 04.812.007S–017S, 04.812.207S–217S).

This addendum includes information on the correct attachment of the implants and trials to the applicator and the final implant positioning.

Fig. 1 Advanced Applicator (03.812.520/521)

Fig. 2 Standard Applicator (03.812.001/003)

10.8 mm

12.4 mm

2 DePuy Synthes T-PAL™ Interbody System Addendum to Surgical Technique

Surgical Technique: Key Points

Instruments

03.812.520 Advanced Applicator Outer Shaft

03.812.521 Advanced Applicator Inner Shaft

03.812.004 Applicator Knob

If using the T-PAL Advanced Applicator take note of the following key points in addition to the other details described in the complete T-PAL surgical technique (SE_811178).

The T-PAL Advanced Applicator Outer Shaft and Inner Shaft have three etch lines (Figure 3) to distinguish them from the standard applicator Outer Shaft and Inner Shaft. Note that the Advanced Applicator Outer Shaft is compatible with the existing trial implants (03.812.307–317 and 03.812.507–517) but the shaft of the trial implants does not have three etch lines.

Warning: The clamp on the Inner Shaft of the Advanced Applicator is asymmetric. When attaching the implant to the applicator the longer finger must be attached to the lateral (convex) side of the implant (Figure 4). There is an etch line on the edge of the longer finger so that proper attachment can be confirmed (Figure 5).

Fig. 3

Fig. 4

Fig. 5

T-PAL™ Interbody System Addendum to Surgical Technique DePuy Synthes 3

Precaution: With the Advanced Applicator it is possible for the implant to pivot greater than 90 degrees (Figure 6). Therefore, careful attention should be paid to fluoroscopy to ensure the implant is in the desired position (see Figures 7–10).

Warning: The T-PAL Advanced Applicator Outer Shaft and Inner Shaft should not be used in combination with the standard Applicator Outer Shaft (03.812.001) and Inner Shaft (03.812.003).

Fig. 6

4 DePuy Synthes T-PAL™ Interbody System Addendum to Surgical Technique

Surgical Technique: Implant Positioning and Verification

T-PAL Implant (PEEK)From the lateral view the T-PAL implant markers should appear as one single line as they will be superimposed one on top of the other if the implant is properly seated (Figure 7). The distance from the superimposed line to the edge of the PEEK is approximately 2 mm. Addition-ally the horizontal marker will appear as a single dot.

Verify that the T-PAL implant is properly positioned in the AP view. If properly seated, the vertical markers should appear to be equidistant from the midline of the spinous process of the spinal column. The horizontal marker will appear perpendicular to the vertical markers. From an AP perspective these two markers will straddle the spinous process (Figure 8).

T-PAL Implant (Titanium)From the lateral view the T-PAL Ti implant should show a visible circular window if the implant has been pivoted into the proper position (Figure 9).

Verify that the implant is properly positioned in the AP view. If properly seated, the furthermost right window on the T-PAL Ti implant shall be centrally located inline with the spinous process of the spinal column (Figure 10).

Fig. 7

Fig. 9

Fig. 8

Fig. 10

Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11www.jnjmedicaldevices.com

Not all products are currently available in all markets.

This publication is not intended for distribution in the USA.

Surgical techniques are available as PDF files at www.depuysynthes.com/ifu ©

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