# K191212: CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Medos International SARL
- Decided: Sep 24, 2019 after 141 days
- Product code: PGM (Growing Rod System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K040583 (2004). 223 ancestors in all.
No later device cites it as a predicate yet.
0 of 224 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160904: Expedium Spine System, VIPER and VIPER 2 Systems, Medos International SARL (2016) Summary page 12.
- K012971: Isola Spinal Systems, Depuyacromed (2001) Summary page 12.
- K021879: Crossover Cross Connector (Isola Spinal System), Depuyacromed (2002) Summary page 12.
- K113396: Depuy Pulse Thoracolumbar Screw System, Medos International SARL (2012) Summary page 12.
- K160879: CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems, Medos International Sàrl (2016) Summary page 12.
- K111136: Expedium Spine System, Viper System, Viper 2 System, Depuy Spine, Inc. (2012) Summary page 12.
- K142185: Expedium Verse Spine System, Depuy Spine, Inc. (2014) Summary page 12.
- K173095: VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations, Medos International SARL (2017) Summary page 12.
- K001372: E-Z Link Cross Connector, Depuyacromed (2000) Summary page 12.
- K003822: Isola Closed Dual Rod Connector, Depuyacromed (2001) Summary page 12.
- K010972: Isola Band Clamp, Depuyacromed (2001) Summary page 12.
- K013441: Isola Polyaxial Washer, Depuyacromed (2001) Summary page 12.
- K022285: Modification to Isola Spinal System, Depuyacromed (2002) Summary page 12.
- K884163: Acromed Spinal Rod and Spinal Hooks, Buckman Co., Inc. (1989) Summary page 12.
- K895441: Acromed Button Spinal Wire, Acromed Corp. (1989) Summary page 12.
- K905184: Isola (TM) Spine System Top Entry Hook, Acromed Corp. (1991) Summary page 12.
- K905826: Isola Slotted Connect/Angled Slotted Connector, Acromed Corp. (1991) Summary page 12.
- K921090: Isola (R) Transverse Rod Dual Connector, Acromed Corp. (1992) Summary page 12.
- K922504: Isola (R) Tandem Connector, Acromed Corp. (1993) Summary page 12.
- K922952: Songer Cable System, Pioneer Surgical Technology (1993) Summary page 13.
- K943819: Isola Anterior System, Acromed Corp. (1995) Summary page 13.
- K944737: Isola Spine System, Acromed Corp. (1995) Summary page 13.
- K951116: Acromed Pedicle Screw, Acromed Corp. (1995) Summary page 13.
- K952236: Isola System, Acromed Corp. (1996) Summary page 13.
- K962645: Isola Twister Connector, Acromed Corp. (1996) Summary page 13.
- K964007: Acromed Cable/Wire Pedicle Screw, Acromed Corp. (1996) Summary page 13.
- K971248: Kaneda SR Anterior Spinal System, Acromed Corp. (1997) Summary page 13.
- K974757: Kaneda Anterior Scoliosis System Kass, Acromed Corp. (1998) Summary page 13.
- K980485: Isola Spinal System, Acromed Corp. (1998) Summary page 13.
- K981113: Pediatric PRC, Acromed Corp. (1998) Summary page 13.
- K984350: VSP System, Depuy Motech Acromed (1999) Summary page 13.
- K010576: Monarch Spine System, Depuyacromed (2001) Summary page 13.
- K021148: Monarch Spine System Commercially Pure Titanium Spinal Rod, Depuyacromed (2002) Summary page 13.
- K023438: Modification to Monarch Spine System, Depuyacromed (2002) Summary page 13.
- K024348: Monarch Spine System, Depuyacromed (2003) Summary page 13.
- K001105: Moss Miami 6.35MM Rod System Pedicle and Laminar Hooks, Depuyacromed (2000) Summary page 13.
- K002607: Moss Miami 6.35MM Rod System Monoaxial Screws, Polyaxial Reduction Screws and Sacral Extenders, Depuyacromed (2000) Summary page 13.
- K010742: Moss Miami 5.5MM Titanium Pin Nut, Depuyacromed (2001) Summary page 13.
- K011182: Modified Moss Miami 4.35MM Diameter Polyaxial Screws, Depuyacromed (2001)
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System), Depuyacromed (2002) Summary page 13.
- K023804: Moss Miami Spinal System Pin Nut, Depuyacromed (2003) Summary page 13.
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws, Depuyacromed (2003) Summary page 13.
- K103490: Expedium Spine System, Moss Miami Spine System, Johnson & Johnson (2011) Summary page 13.
- K760649: Total Spinal Correction, Depuy, Inc. (1976) Summary page 13.
- K894184: Biedermann Motech Universal Spinal System, Biedermann Motech GmbH (1990) Summary page 13.
- K933881: Depuy Motech Moss-Miami Spinal System, Depuy, Inc. (1994) Summary page 13.
- K950695: Depuy Motech Moss Spinal System - Pedicle Fixation, Depuy Motech (1995) Summary page 13.
- K953915: Moss Miami Spinal System (Anterior Use), Depuy, Inc. (1996) Summary page 13.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 13.
- K962628: Moss Miami Spinal System, Depuy, Inc. (1997) Summary page 13.
- K964024: Depuy Motech Titanium Moss Miami Spinal System, Depuy, Inc. (1997) Summary page 13.
- K972568: Depuy Motech Moss-Miami Spinal System, Depuy, Inc. (1997) Summary page 13.
- K980447: Depuy Motech Moss Miami Spinal System, DePuy Orthopaedics, Inc. (1998) Summary page 13.
- K982011: Depuy Motech Moss Miami Spinal System, DePuy Orthopaedics, Inc. (1998) Summary page 13.
- K982320: Depuy Motech Moss Miami Spinal System, Depuy, Inc. (1998) Summary page 13.
- K983583: Depuy Acromed Moss and Moss Miami Spinal Systems, Depuy, Inc. (1998) Summary page 13.
- K984378: Depuy Acromed Moss Spinal System, Depuy, Inc. (1998) Summary page 13.
- K992168: Moss Miami 6.35MM Polyaxial Screw, Depuyacromed (1999) Summary page 13.
- K984348: Timx Low Back System, Depuy Motech Acromed (1999) Summary page 13.
- K162912: VIPER PRIME™ additions to the VIPER® System, Medos International SARL (2016) Summary page 13.
- K170543: VIPER PRIME™ Screws with Fenestrations, Medos International SARL (2017) Summary page 13.
- K171570: Additional VIPER PRIME™ screws with fenestrations, Medos International SARL (2017) Summary page 13.
- K121020: Viper System, Depuy Spine, Inc. (2012) Summary page 13.
- K101993: Viper System, Expedium System, Depuy Spine, Inc. (2010) Summary page 13.
- K102701: Viper Spine System, Depuy Spine, Inc. (2010) Summary page 13.
- K110216: Expedium System, Viper System, Depuy Spine, Inc. (2011) Summary page 13.
- K111571: Viper Systems, Johnson & Johnson (2011) Summary page 13.
- K944736: VSP (Variable Screw Placement), Acromed Corp. (1995) Summary page 13.
- K965102: Acromed Pedicle Screw, Acromed Corp. (1997) Summary page 13.

## Indications for use
The DePuy PULSE Thoracolumbar Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The DePuy PULSE Thoracolumbar Screw System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. The ISOLA, VSP, MOSS MIAMI, TiMX, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems are pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The ISOLA, VSP, MOSS MIAMI, TiMX, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems are also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The ISOLA, MOSS MIAMI, TiMX, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems are also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). The ISOLA, VSP, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine. The ISOLA and MOSS MIAMI Spine Systems when used as anterior thoracic/lumbar screw fixation systems, are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis). The MONARCH Spine System Dual Rod Connectors can be used to connect MONARCH Spine System Rods to rods of other DePuy Spine 4.75mm, 5.5mm, and 6.35mm diameter rod systems. The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in posterior spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available EXPEDIUM, VIPER, VSP, ISOLA, MONARCH, MOSS MIAMI, and TiMX Spine Systems. Please refer to the labeling of the aforementioned spinal systems for each system's indications for use. The EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER System, VIPER 2 System, VIPER SAI, and VIPER PRIME is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER System, VIPER 2 System, VIPER SAI, and VIPER PRIME is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in a posterior percutaneous approach with MIS instrumentation, the EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER System, VIPER 2 System, VIPER SAI, and VIPER PRIME is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER System and VIPER 2 System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER System, VIPER 2 System, and VIPER PRIME are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. The EXPEDIUM Growing Spine System is indicated for patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The EXPEDIUM Growing Spine System may be used with any cleared traditional 4.5 and 5.5 EXPEDIUM Spine Systems. The EXPEDIUM Growing Spine System is not intended to be used with 4.0mm diameter screws. When used in conjunction with CONFIDENCE High Viscosity Spinal Cement, the VIPER and EXPEDIUM Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER and EXPEDIUM Fenestrated Screw Systems augmented with the CONFIDENCE High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Source page: https://510kreport.com/device/K191212
Methodology: https://510kreport.com/methodology