510(k) Report

510(k) · Cleared

Cleared

Astra Spine System

K150417510(k) TraditionalCleared May 19, 201590-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spinecraft, LLC · NKB Thoracolumbosacral Pedicle Screw System

Cleared on May 19, 2015 as substantially equivalent to K131802 (Depuy Spine, A Johnson & Johnson Company, 2013) and 14 other predicates after a 90-day review. Its family tree reaches back 14 generations to 1985. 21 later devices descend from it.

Decided
May 19, 2015
Review
90 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
15

Its longest line of descent runs back 14 generations to K853033 (1985). 197 ancestors in all, the oldest K781443 (1978). 21 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2012: 3 other ancestors2010: 11 other ancestors2009: 8 other ancestors2008: 12 other ancestors2007: 5 other ancestors2006: 11 other ancestors2000: 15 other ancestors1996: 9 other ancestors1995: 7 other ancestors2011: 3 other ancestors2005: 12 other ancestors2004: 16 other ancestors2003: 10 other ancestors2002: 9 other ancestors2001: 12 other ancestors1998: 12 other ancestors1997: 6 other ancestors1994: 3 other ancestors1978: 1 other ancestor1999: 8 other ancestors1993: 2 other ancestors1992: 5 other ancestors1990: 2 other ancestors2021: 2 descendants cleared2017: 1 descendant cleared2022: 3 descendants cleared2018: 2 descendants cleared2024: 2 descendants cleared2023: 3 descendants cleared2025: 5 descendants cleared2019: 1 descendant cleared2026: 2 descendants clearedK853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001×2: 2 generations cleared close together, K022190 (2002), K030103 (2003) K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004×3: 3 generations cleared close together, K062174 (2006), K063156 (2006), K063741 (2007) K080313 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2008K101993 · Viper System, Expedium System · Depuy Spine, Inc. · 2010 · recalledK131802 · Expedium, Viper. Viper 2 Spine System · Depuy Spine, A Johnson & Johnson Company · 201319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 14 other ancestors2 generations back: 41 other ancestors3 generations back: 34 other ancestors4 generations back: 36 other ancestors5 generations back: 35 other ancestors6 generations back: 11 other ancestors7 generations back: 12 other ancestors 1 generation forward: 4 descendants2 generations forward: 6 descendants3 generations forward: 10 descendants4 generations forward: 1 descendant K131802 · Expedium, Viper. Viper 2 Spine System · Depuy Spine, A Johnson & Johnson Company · 2013K101993 · Viper System, Expedium System · Depuy Spine, Inc. · 2010 · recalledK080313 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2008K063741 · Expedium Spine System · Depuy Spine, Inc. · 2007K063156 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K062174 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985−10−50
  1. Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 10 generations between
  3. 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
  4. 2 generations backK101993 Viper System, Expedium SystemDepuy Spine, Inc. · 2010 · Recalled
  5. 1 generation backK131802 Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company · 2013
  6. This deviceK150417 Astra Spine SystemSpinecraft, LLC · 2015
  7. Descendant · cites it directly · 12 of its ownK211323 ASTRA Spine SystemSpinecraft, LLC · 2021
  8. Descendant · cites it directly · 8 of its ownK223273 ASTRA Spine SystemSpinecraft, LLC · 2022
  9. Descendant · cites it directly · 6 of its ownK162786 PASS LP Spinal SystemMedicrea International SA · 2017
  10. Descendant · 2 generations on · 5 of its ownK233508 iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024
  11. Descendant · 2 generations on · 2 of its ownK221776 NextGen Pedicle Screw SystemCorelink, LLC · 2022
Show all 14 generations
  1. Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 13 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 12 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 11 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 10 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 9 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 8 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 7 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 6 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  10. 5 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  11. 4 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
  12. 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
  13. 2 generations backK101993 Viper System, Expedium SystemDepuy Spine, Inc. · 2010 · Recalled
  14. 1 generation backK131802 Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company · 2013
  15. This deviceK150417 Astra Spine SystemSpinecraft, LLC · 2015

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2017: 12018: 22019: 12021: 22022: 32023: 32024: 22025: 52026: 2
2017high 5 (2025) · low 0 (2020)2026

Most influential descendants

Showing 5 of 21 · See all
  • K211323ASTRA Spine SystemSpinecraft, LLC · 2021 · cites it directly12descendants
  • K223273ASTRA Spine SystemSpinecraft, LLC · 2022 · cites it directly8descendants
  • K162786PASS LP Spinal SystemMedicrea International SA · 2017 · cites it directly6descendants
  • K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024 · 2 generations on5descendants
  • K221776NextGen Pedicle Screw SystemCorelink, LLC · 2022 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−13K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−12K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−11K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−10K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−9K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−8K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−7K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−6K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−5K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−4K063741Expedium Spine SystemDepuy Spine, Inc.2007—
−3K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008—
−2K101993Viper System, Expedium SystemDepuy Spine, Inc.20108
−1K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013—
0 (this device)K150417Astra Spine SystemSpinecraft, LLC2015—
+1K211323ASTRA Spine SystemSpinecraft, LLC2021—
+1K223273ASTRA Spine SystemSpinecraft, LLC2022—
+1K162786PASS LP Spinal SystemMedicrea International SA2017—
+2K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.2024—
+2K221776NextGen Pedicle Screw SystemCorelink, LLC2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
199020
199250
199320
199430
199570
199690
199760
1998120
199980
2000150
2001120
200290
2003100
2004160
2005120
2006110
200750
2008120
200980
2010110
201130
201230
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201820
201910
202120
202230
202330
202420
202550
202620
FIG. 1 — Lineage of K150417, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NKB device

  1. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (15)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K131802Expedium, Viper. Viper 2 Spine System
Summary page 4
…8.3060 Class III 3. Primary predicate or legally marketed device which is substantially equivalent: • Expedium,Viper Spine System (K131802) DePuy Spine 4. Additional predicate devices: • APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineC…
Depuy Spine, A Johnson & Johnson Company2013—
*K062513Apex Spine System
Summary page 4
…marketed device which is substantially equivalent: • Expedium,Viper Spine System (K131802) DePuy Spine 4. Additional predicate devices: • APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineCraft • Xia Spinal System (K060748 / K071373 / K113666) Stryker • Rogozin…
Spinecraft, Inc.2006—
*K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer
Summary page 4
…evice which is substantially equivalent: • Expedium,Viper Spine System (K131802) DePuy Spine 4. Additional predicate devices: • APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineCraft • Xia Spinal System (K060748 / K071373 / K113666) Stryker • Rogozinski (K9546…
Spinecraft, Inc.2010—
*K102488Apex Spine System W/ Cocr Rods
Summary page 4
…h is substantially equivalent: • Expedium,Viper Spine System (K131802) DePuy Spine 4. Additional predicate devices: • APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineCraft • Xia Spinal System (K060748 / K071373 / K113666) Stryker • Rogozinski (K954696) Smith…
Spinecraft, LLC2010—
*K132603Apex Spine System
Summary page 4
…quivalent: • Expedium,Viper Spine System (K131802) DePuy Spine 4. Additional predicate devices: • APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineCraft • Xia Spinal System (K060748 / K071373 / K113666) Stryker • Rogozinski (K954696) Smith Nephew • Silhou…
Spinecraft, LLC2013—
*K090648Viper 2 System
Summary page 4
…cate devices ASTRA Spine System is substantially equivalent to the APEX Spine System (K062513 / K092825 / K102488 / K132603), Expedium Viper Spine System (K090648 / K102701 / K131802), Xia Spine System (K060748 / K071373 / K113666), Rogozinski (K954696), MOSS MIAMI SS…
Depuy Spine, Inc.2009—
*K102701Viper Spine System
Summary page 4
…es ASTRA Spine System is substantially equivalent to the APEX Spine System (K062513 / K092825 / K102488 / K132603), Expedium Viper Spine System (K090648 / K102701 / K131802), Xia Spine System (K060748 / K071373 / K113666), Rogozinski (K954696), MOSS MIAMI SS…
Depuy Spine, Inc.2010—
*K060748Modification to Xia 4.5 Spinal System
Summary page 4
…(K131802) DePuy Spine 4. Additional predicate devices: • APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineCraft • Xia Spinal System (K060748 / K071373 / K113666) Stryker • Rogozinski (K954696) Smith Nephew • Silhouette (K980288) Zimmer Spine • MOSS MIAMI…
Stryker Spine2006—
*K071373Stryker Spine Xia Iii Spinal System
Summary page 4
…DePuy Spine 4. Additional predicate devices: • APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineCraft • Xia Spinal System (K060748 / K071373 / K113666) Stryker • Rogozinski (K954696) Smith Nephew • Silhouette (K980288) Zimmer Spine • MOSS MIAMI SS (K95069…
Stryker Spine20071
*K113666Xia 3 Spinal System
Summary page 4
…ne 4. Additional predicate devices: • APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineCraft • Xia Spinal System (K060748 / K071373 / K113666) Stryker • Rogozinski (K954696) Smith Nephew • Silhouette (K980288) Zimmer Spine • MOSS MIAMI SS (K950697 / K00053…
Stryker Spine2012—
*K954696Rogozinski Thoracolumbar Spinal Rod
Summary page 4
…• APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineCraft • Xia Spinal System (K060748 / K071373 / K113666) Stryker • Rogozinski (K954696) Smith Nephew • Silhouette (K980288) Zimmer Spine • MOSS MIAMI SS (K950697 / K000536) DePuy Spine • Synergy VLS –…
Smith & Nephew Richards, Inc.1996—
*K950697Depuy Motech Moss Miami Spinal System - Pedicle Fixation
Summary page 4
…ft • Xia Spinal System (K060748 / K071373 / K113666) Stryker • Rogozinski (K954696) Smith Nephew • Silhouette (K980288) Zimmer Spine • MOSS MIAMI SS (K950697 / K000536) DePuy Spine • Synergy VLS – open – (K940631) Cross Medical • Ti Expedium 4.5 Spine System (K081252) DePuy Sp…
Depuy Motech1995—
*K000536Synthes Anterior CSLP System
Summary page 4
…Xia Spinal System (K060748 / K071373 / K113666) Stryker • Rogozinski (K954696) Smith Nephew • Silhouette (K980288) Zimmer Spine • MOSS MIAMI SS (K950697 / K000536) DePuy Spine • Synergy VLS – open – (K940631) Cross Medical • Ti Expedium 4.5 Spine System (K081252) DePuy Spine 5. De…
Synthes Spine20001
*K940631Cross Medical - Synergy (TM) Spine System
Summary page 4
…ryker • Rogozinski (K954696) Smith Nephew • Silhouette (K980288) Zimmer Spine • MOSS MIAMI SS (K950697 / K000536) DePuy Spine • Synergy VLS – open – (K940631) Cross Medical • Ti Expedium 4.5 Spine System (K081252) DePuy Spine 5. Description of the device: The ASTRA Spine S…
Cross Medical Products, Inc.1995—
*K081252Expedium 4.5MM Spine System
Summary page 4
…ette (K980288) Zimmer Spine • MOSS MIAMI SS (K950697 / K000536) DePuy Spine • Synergy VLS – open – (K940631) Cross Medical • Ti Expedium 4.5 Spine System (K081252) DePuy Spine 5. Description of the device: The ASTRA Spine System is a top loading, multiple component, posterior spinal…
Depuy Spine, Inc.2008—

Also cleared against K131802: 13 other devices →

What descends from it? (21)

See all 21

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K211323ASTRA Spine SystemSpinecraft, LLC202112
K223273ASTRA Spine SystemSpinecraft, LLC20228
K162786PASS LP Spinal SystemMedicrea International SA20176
K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
  • 16 of the 197 ancestors have a recall of any class.
  • Of its descendants, K211323 (Spinecraft, LLC, 2021) has gone furthest, with 12 descendants of its own.
  • 13 other devices also cite its predicate K131802.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The ASTRA Spine System is 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis…

Read the full statement (277 words)

The ASTRA Spine System is 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudo-arthrosis).

The ASTRA Spine System is 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, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.

The ASTRA Spine System is also a sacral/iliac screw fixation system of the non-cervical 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 (pseudo-arthrosis).

When used in a percutaencous, posterior approach with AVANT Spine MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain 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, pseudo-arthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K131802

13 other devices cite the same predicate.

  • K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA · 2021
  • K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG · 2021
  • K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd. · 2020
  • K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI…Medos International SARL · 2019
  • K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA · 2019
  • K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG · 2018

More from Spinecraft, LLC

12 FDA decisions under this applicant name. See the company

  • K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC · 2023
  • K223273ASTRA Spine SystemSpinecraft, LLC · 2022
  • K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC · 2021
  • K211323ASTRA Spine SystemSpinecraft, LLC · 2021
  • K181350ASTRA-OCT Spine SystemSpinecraft, LLC · 2018

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K150417 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150417: Astra Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150417

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026