CAPTIVA SPINE, Inc.
Jupiter, FL, US
CAPTIVA SPINE, Inc. appears in FDA device records in Jupiter, FL. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for CAPTIVA SPINE, Inc. between 2009 and 2020. The busiest year on record is 2012, with 3. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2011 | 2 |
| 2012 | 3 |
| 2013 | 1 |
| 2015 | 3 |
| 2016 | 1 |
| 2018 | 3 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K193270 | CapLOX II®/TowerLOX® MIS Pedicle Screw System | NKB | Substantially Equivalent | |
| K181229 | TirboLOX-C Cervical IBFD | ODP | Substantially Equivalent | |
| K180990 | TirboLOX-L Lumbar IBFD | MAX | Substantially Equivalent | |
| K180475 | CapLOX II® / TowerLOX® MIS Pedicle Screw System | NKB | Substantially Equivalent | |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System | MNH | Substantially Equivalent | |
| K151116 | CapLOX II/TowerLOX Pedicle Screw System | MNH | Substantially Equivalent | |
| K141332 | Captiva Spine SmartLOX Cervical Plate System | KWQ | Substantially Equivalent | |
| K142586 | Captiva Spine FuselOX Cervical IBF System | ODP | Substantially Equivalent | |
| K131538 | CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM | MNH | Substantially Equivalent | |
| K122956 | FUSELOX LUMBAR INTERBODY FUSION DEVICE | MAX | Substantially Equivalent | |
| K122332 | TOWERLOX PEDICLE SCREW SYSTEM | MNI | Substantially Equivalent | |
| K120292 | CAPLOX II PEDICLE SCREW SYSTEM | MNI | Substantially Equivalent | |
| K111115 | CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM | MNI | Substantially Equivalent | |
| K110585 | CAPTIVA SPINE FUSELOX CERVICAL CAGE | ODP | Substantially Equivalent | |
| K092017 | PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) | MAX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006082533 | 3006082533 | CAPTIVA SPINE, Inc. | 967 N HIGHWAY A1A ALT STE 1, Jupiter, FL 33477 US | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HTWBit, Drill
- HTFCurette
- FZXGuide, Surgical, Instrument
- GDZHandle, Scalpel
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- HXLMallet
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- GFIOsteotome, Manual
- HTXRongeur
- OURSacroiliac Joint Fixation
- HXGTamp
- NKBThoracolumbosacral Pedicle Screw System
- FSMTray, Surgical, Instrument
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1480-2015 | Captiva's lumbar intervertebral fusion system Reamers (color code rings on the Reamers). | It is possible for the titanium color-coded ring to detach from the Reamers. | Class II | Terminated | |
| Z-0413-2013 | CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation system 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion. | Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking | Class II | Terminated | |
| Z-1786-2012 | Accessories for the Captiva Spine FuseLOX Lumbar Cage. The FuseLOX Lumbar Inserter product is a reuseable component of the Captiva Spine FuseLOX Lumbar product. It is not generally sold as an individually packaged product. Inserter products are shipped as a component of the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. FPT - F is FuseLOX, P is Plif, and I is Inserter. Products subject to recall: FuseLOX Lumbar Inserter Inserter - Part Number: FPT0200 Lot Number 6110100. Quantity distributed (8) is found in table on page 5 of 6. The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. | Captiva Spine, Inc. initiated a recall of FuseLOX Lumbar Implants, Trials, and Inserters after FDA advised the firm that there is inadequate support for implemented design changes to the cleared device Pivotec Lumbar Interbody Fusion Device. | Terminated | ||
| Z-1785-2012 | Accessories for the Captiva Spine FuseLOX Lumbar Cage. The Trial product is a reuseable component of the Captiva Spine FuseLOX Lumbar product. It is not generally sold as an individually packaged product. Trial products are shipped as a component of the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. FPT - F is FuseLOX, P is Plif, and T is Trial. Products subject to recall: FuseLOX Lumbar Trials Trial - 7mm x 25mm Part Number: FPT2507 Lot Number 8110001. Trial - 8mm x 25mm Part Number FPT2508 Lot Number 8110002. Trial - 9mm x 25mm Part Number: FPT2509 Lot Number 8110003. Trial - 10mm x 25mm Part Number: FPT2510 Lot Number 8110004. Trial - 11mm x 25mm Part Number: FPT2511 Lot Number 8110005. Trial - 12mm x 25mm Part Number: FPT2512 Lot Number 8110006. Trial - 13mm x 25mm Part Number FPT2513 Lot Number 8110007. Trial - 14mm x 25mm Part Number FPT2514 Lot Number 8110008. The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. | Captiva Spine, Inc. initiated a recall of FuseLOX Lumbar Implants, Trials, and Inserters after FDA advised the firm that there is inadequate support for implemented design changes to the cleared device Pivotec Lumbar Interbody Fusion Device. | Terminated | ||
| Z-1784-2012 | Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part: "FuseLOX Lumbar Cage Lumbar Interbody Fusion Device***Description:***Part Number:***Lot Number:***Quantity: 1***Material: PEEK-OPTIMA LT1, Tantalum ASTM F560***Non-Sterile-Single Use Only (See package insert for sterilization parameters and labeling.)***CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.***Manufactured and distributed by: CAPTIVA SPINE***captivaspine.com***967 Alternate A1A #1 Jupiter, FL 33477 Tel: 877-772-5571 Fax: 866-318-3224 Email: [email protected]***" FPL - F is FuseLOX, P is Plif, C is Lorditic Products subject to recall: FuseLOX Lumbar Lorditic: Lorditic - 7mm x 25mm Part Number: FPL2507 Lot Number 07110010. Lorditic - 8mm x 25mm Part Number FPL2508 Lot Number 07110011. Lorditic - 9mm x 25mm Part Number: FPL2509 Lot Number 07110012. Lorditic - 10mm x 25mm Part Number: FPL2510 Lot Number 07110013. Lorditic - 11mm x 25mm Part Number: FPL2511 Lot Number 07110014. Lorditic - 12mm x 25mm Part Number: FPL2512 Lot Number 07110015. Lorditic - 13mm x 25mm Part Number FPL2513 Lot Number 07110016. Products are packaged individually and shipped as replacement parts to be placed in the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. | Captiva Spine, Inc. initiated a recall of FuseLOX Lumbar Implants, Trials, and Inserters after FDA advised the firm that there is inadequate support for implemented design changes to the cleared device Pivotec Lumbar Interbody Fusion Device. | Terminated | ||
| Z-1783-2012 | Accessories for the Captiva Spine FuseLOX Lumbar Cage. Products are labeled in part: "FuseLOX Lumbar Cage Lumbar Interbody Fusion Device***Description:***Part Number:***Lot Number:***Quantity: 1***Material: PEEK-OPTIMA LT1, Tantalum ASTM F560***Non-Sterile-Single Use Only (See package insert for sterilization parameters and labeling.)***CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.***Manufactured and distributed by: CAPTIVA SPINE***captivaspine.com***967 Alternate A1A #1 Jupiter, FL 33477 Tel: 877-772-5571 Fax: 866-318-3224 Email: [email protected]***" FPC - F is FuseLOX, P is Plif, C is Convex Products subject to recall: Convex - 7mm x 25mm Part Number: FPC2507 Lot Number 07110002. Convex - 8 mm x 25mm Part Number FPC2508 Lot Number 07110003. Convex - 9mm x 25mm Part Number: FPC2509 Lot Number 07110004. Convex - 10mm x 25mm Part Number: FPC2510 Lot Number 07110005. Convex - 11mm x 25mm Part Number: FPC2511 Lot Number 07110006. Convex - 12mm x 25mm Part Number: FPC2512 Lot Number 07110007. Convex - 13mm x 25mm Part Number FPC2513 Lot Number 07110008. Convex - 14mm x 25mm Part Number FPC2514 Lot Number 07110009. Products are packaged individually and shipped as replacement parts to be placed in the FuseLOX Lumbar Caddy which is placed in the FuseLox Lumbar Sterilization tray. The sterilization tray is distributed on consignment. The FuseLOX Lumbar Cage implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Cage Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. | Captiva Spine, Inc. initiated a recall of FuseLOX Lumbar Implants, Trials, and Inserters after FDA advised the firm that there is inadequate support for implemented design changes to the cleared device Pivotec Lumbar Interbody Fusion Device. | Terminated | ||
| Z-1545-2012 | Instructions For Use: "***SmartLOX***Instructions for Use Cervical Plate System***STERILIZATION***The SmartLOX Cervical Plate System components are supplied clean and not sterile. All implants and instruments should be cleaned and sterilized prior to surgery. AORN recommended practices for in hospital sterilization should be followed. Sterilization testing of components has shown the following recommendations for sterilization are effective Method: Steam***Cycle: Pre vacuum***Temperature 270 F (132 C)***Exposure Time: 3 minutes***Contact Information: Captiva Spine Inc. 967 Alternate AA #1 Jupiter, FL 33477. Tel: 877-772-5571***CAPTIVA SPINE***". Intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. | Captiva Spine has initiated a correction of the SmartLOX Instructions for Use (IFU) for SmartLOX Cervical Plate System. The pre vacuum sterilization cycle [270 (132 C) for 3 minutes] has not been validated. | Terminated | ||
| Z-1649-2012 | Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP50150***Single Barrel Variable Drill Guide***Lot Number 1500705A or Lot Number 06110041***" "***Part Number CP50160***Single Barrel Fixed Drill Guide***Lot Number 1500707A or Lot Number 06110043***" "***Part Number CP50170***Double Barrel Fixed Drill Guide***Lot Number 1500708A or Lot Number 06110044***" Products are packaged individually and shipped as replacement parts to be placed in the SmartLOX Cervical Plate System tray. The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. | Captiva Spine is recalling the SmartLOX Cervical Plate components 12 & 14 mm Drill Bits, Single Barrel Variable Drill Guides, and Double Barrel Fixed Drill Guides. The components are part of the instrumentation kit used to complete an anterior screw fixation of the cervical spine. There is a potential risk for the drills to not properly fit through the drill guides due to an overlap in the dime | Terminated | ||
| Z-1648-2012 | Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP40012***12mm Drill Bit***Lot Number 89427-2 R***" "***Part Number CP40014***14mm Drill Bit***Lot Number 89427-3-R***" The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. | Captiva Spine is recalling the SmartLOX Cervical Plate components 12 & 14 mm Drill Bits, Single Barrel Variable Drill Guides, and Double Barrel Fixed Drill Guides. The components are part of the instrumentation kit used to complete an anterior screw fixation of the cervical spine. There is a potential risk for the drills to not properly fit through the drill guides due to an overlap in the dime | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain