510(k) Report

510(k) · Cleared

Cleared

Nile Alternative Fixation

K143350510(k) TraditionalCleared Feb 25, 201593-day reviewClass II21 CFR 888.3010

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

K2m, Inc. · OWI Bone Fixation Cerclage, Sublaminar

Cleared on Feb 25, 2015 as substantially equivalent to K110348 (Zimmer Spine, 2011) and 8 other predicates after a 93-day review. Its family tree reaches back 8 generations to 1995. 10 later devices descend from it.

Decided
Feb 25, 2015
Review
93 days
Class
Class II
Product code
OWI
Recalls
None
Predicates
9

Its longest line of descent runs back 8 generations to K950697 (1995). 76 ancestors in all, the oldest K781443 (1978). 10 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2014: 1 other ancestor2013: 1 other ancestor2012: 2 other ancestors2011: 3 other ancestors2009: 2 other ancestors2008: 7 other ancestors2006: 4 other ancestors2010: 1 other ancestor2007: 2 other ancestors2005: 6 other ancestors2002: 1 other ancestor2000: 5 other ancestors1997: 3 other ancestors1996: 3 other ancestors1993: 2 other ancestors1992: 1 other ancestor2004: 6 other ancestors1998: 2 other ancestors1994: 1 other ancestor2003: 6 other ancestors2001: 6 other ancestors1999: 2 other ancestors1978: 1 other ancestor2024: 3 descendants cleared2016: 1 descendant cleared2017: 3 descendants cleared2023: 2 descendants cleared2026: 1 descendant clearedK950697 · Depuy Motech Moss Miami Spinal System - Pedicle Fixation · Depuy Motech · 1995×4: 4 generations cleared close together, K050461 (2005), K052761 (2005), K060361 (2006), K060979 (2006) ×2: 2 generations cleared close together, K082942 (2008), K090230 (2009) K120099 · Range Spinal System (Mesa and Denali) · K2m, Inc. · 201219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 14 other ancestors3 generations back: 15 other ancestors4 generations back: 20 other ancestors5 generations back: 7 other ancestors6 generations back: 3 other ancestors7 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K120099 · Range Spinal System (Mesa and Denali) · K2m, Inc. · 2012K090230 · Expedium Spine System · Depuy Spine, Inc. · 2009K082942 · Modfication to: Expedium Spine System · Depuy Spine, Inc. · 2008K060979 · Xia Titanium and 4.5 Spinal Systems · Stryker Spine · 2006K060361 · Xia Spinal System, Xia 4.5 Spinal System · Stryker Spine · 2006 · recalledK052761 · Modification to: Xia 4.5 Spinal System · Stryker Spine · 2005K050461 · Xia 4.5 Spinal System · Stryker Spine · 2005K950697 · Depuy Motech Moss Miami Spinal System - Pedicle Fixation · Depuy Motech · 1995−50
  1. Root · 8 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
  2. 7 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
  3. 6 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
  4. 5 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
  5. 4 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
  6. 3 generations backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
  7. 2 generations backK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009
  8. 1 generation backK120099 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
  9. This deviceK143350 Nile Alternative FixationK2m, Inc. · 2015
  10. Descendant · cites it directly · 5 of its ownK161332 NILE Proximal Fixation Spinal SystemK2m, Inc. · 2017
  11. Descendant · cites it directly · 5 of its ownK160208 NILE Alternative Fixation Spinal SystemK2m, Inc. · 2016
  12. Descendant · 2 generations on · 4 of its ownK222684 XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal…Stryker Spine · 2023
  13. Descendant · cites it directly · 2 of its ownK163181 TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc. · 2017
  14. Descendant · cites it directly · 1 of its ownK242361 OZARK Cervical Plate System; PYRENEES® Cervical Plate System…Stryker Spine · 2024

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2016: 12017: 32023: 22024: 32026: 1
2016high 3 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 10 · See all
  • K161332NILE Proximal Fixation Spinal SystemK2m, Inc. · 2017 · cites it directly5descendants
  • K160208NILE Alternative Fixation Spinal SystemK2m, Inc. · 2016 · cites it directly5descendants
  • K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine · 2023 · 2 generations on4descendants
  • K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc. · 2017 · cites it directly2descendants
  • K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine · 2024 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K950697Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech1995—
−7K050461Xia 4.5 Spinal SystemStryker Spine2005—
−6K052761Modification to: Xia 4.5 Spinal SystemStryker Spine2005—
−5K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine20061
−4K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006—
−3K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008—
−2K090230Expedium Spine SystemDepuy Spine, Inc.2009—
−1K120099Range Spinal System (Mesa and Denali)K2m, Inc.2012—
0 (this device)K143350Nile Alternative FixationK2m, Inc.2015—
+1K161332NILE Proximal Fixation Spinal SystemK2m, Inc.2017—
+1K160208NILE Alternative Fixation Spinal SystemK2m, Inc.2016—
+2K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System…Stryker Spine2023—
+1K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.2017—
+1K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal…Stryker Spine2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
199210
199320
199410
199630
199730
199820
199920
200050
200160
200210
200360
200460
200560
200640
200720
200870
200920
201010
201130
201220
201310
201410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201730
202320
202430
202610
FIG. 1 — Lineage of K143350, 1995–2026Source: 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 OWI? 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 OWI device

  1. #1 K253615 Invictus Bands Systemscore 20.7 · 33 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? (9)

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
*K110348Universal Clamp Spinal Fixation System
Summary page 4
…Classification Name(s): Bone Fixation Cerclage (21 CFR 888.3010, Product Code OWI) Predicate Device(s) Primary Predicate:  Universal Clamp Spinal Fixation System (K110348, K091190, K081622, K060009) Additional Predicates:  SILC Fixation System (K133482)  LigaPASS (K132395, K112736)  Jaz…
Zimmer Spine2011—
*K091190Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063
Summary page 4
…cation Name(s): Bone Fixation Cerclage (21 CFR 888.3010, Product Code OWI) Predicate Device(s) Primary Predicate:  Universal Clamp Spinal Fixation System (K110348, K091190, K081622, K060009) Additional Predicates:  SILC Fixation System (K133482)  LigaPASS (K132395, K112736)  Jazz System…
Zimmer Spine, Inc.2009—
*K081622Universal Clamp Stainless Steel System
Summary page 4
…me(s): Bone Fixation Cerclage (21 CFR 888.3010, Product Code OWI) Predicate Device(s) Primary Predicate:  Universal Clamp Spinal Fixation System (K110348, K091190, K081622, K060009) Additional Predicates:  SILC Fixation System (K133482)  LigaPASS (K132395, K112736)  Jazz System (K121541)…
Abbott Spine, Inc.2008—
*K060009Abbott Spine Universal Clamp System
Summary page 4
…ne Fixation Cerclage (21 CFR 888.3010, Product Code OWI) Predicate Device(s) Primary Predicate:  Universal Clamp Spinal Fixation System (K110348, K091190, K081622, K060009) Additional Predicates:  SILC Fixation System (K133482)  LigaPASS (K132395, K112736)  Jazz System (K121541)  Ran…
Abbott Spine, Inc.2006—
*K133482Silc Fixation System
Summary page 4
…redicate Device(s) Primary Predicate:  Universal Clamp Spinal Fixation System (K110348, K091190, K081622, K060009) Additional Predicates:  SILC Fixation System (K133482)  LigaPASS (K132395, K112736)  Jazz System (K121541)  Range/Mesa/Denali Spinal System (K120099) Device Description…
Globus Medical, Inc.2014—
*K132395Ligapass
Summary page 4
…ry Predicate:  Universal Clamp Spinal Fixation System (K110348, K091190, K081622, K060009) Additional Predicates:  SILC Fixation System (K133482)  LigaPASS (K132395, K112736)  Jazz System (K121541)  Range/Mesa/Denali Spinal System (K120099) Device Description The Nile Alternative Fi…
Medicrea International2013—
*K112736Pass LP Spinal
Summary page 4
…ate:  Universal Clamp Spinal Fixation System (K110348, K091190, K081622, K060009) Additional Predicates:  SILC Fixation System (K133482)  LigaPASS (K132395, K112736)  Jazz System (K121541)  Range/Mesa/Denali Spinal System (K120099) Device Description The Nile Alternative Fixation Sy…
Medicrea International2012—
*K121541Jazz System
Summary page 4
…pinal Fixation System (K110348, K091190, K081622, K060009) Additional Predicates:  SILC Fixation System (K133482)  LigaPASS (K132395, K112736)  Jazz System (K121541)  Range/Mesa/Denali Spinal System (K120099) Device Description The Nile Alternative Fixation System implants are comprised…
Implanet, S.A.2012—
*K120099Range Spinal System (Mesa and Denali)
Summary page 4
…2, K060009) Additional Predicates:  SILC Fixation System (K133482)  LigaPASS (K132395, K112736)  Jazz System (K121541)  Range/Mesa/Denali Spinal System (K120099) Device Description The Nile Alternative Fixation System implants are comprised of bands, clamps and set screws designed to at…
K2m, Inc.2012—

Also cleared against K110348: 8 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175
K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165
K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172
K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241

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 20 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
  • 3 of the 76 ancestors have a recall of any class.
  • Of its descendants, K161332 (K2m, Inc., 2017) has gone furthest, with 5 descendants of its own.
  • 8 other devices also cite its predicate K110348.

How does its category compare?

All OWI devices

OWI Bone Fixation Cerclage, Sublaminar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · OWI

2in 2023

2011: 12013: 22014: 32015: 32016: 52017: 72018: 42019: 32020: 32021: 12022: 12023: 22026 (partial year): 2
2007high 7 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OWI

60in 2020

2014: 92 days median2015: 93 days median2016: 98 days median2017: 77 days median2018: 156 days median2019: 51 days median2020: 60 days median
2007high 156 (2018) · low 51 (2019)2026

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

Recalls per year · OWI

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OWI

6in 2025

2014: 12015: 12016: 62017: 62018: 22019: 132020: 82021: 52022: 62023: 42024: 32025: 6
2007high 13 (2019) · low 0 (2007)2025

MAUDE reports naming product code OWI, 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
20070—00
20080—00
20090—00
20100—00
20111—00
20120—00
20132—00
201439201
201539301
201659806
201777706
2018415602
2019351013
202036018
20211—05
20221—06
20232—04
20240—03
20250—06
20262—0—

What is it indicated for?

The NILE Alternative Fixation Spinal System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repait of bone fractures. The indications for use include the following applications: 1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques; 2. Spinal reconstructive surgery, incorporated into…

Read the full statement (136 words)

The NILE Alternative Fixation Spinal System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repait of bone fractures.

The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques;

2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;

3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The NILE Alternative Fixation Spinal System may also be used in conjunction with other medical implants made of similar metals whenever 'wiring' may help secure the attachment of other implants.

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 K110348

8 other devices cite the same predicate.

  • K172206NAJA™ Ligament Correction SystemCousin Biotech Sas · 2018
  • K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc. · 2017
  • K161267Response BandLoc Spinal FixationOrthoPediatrics Corp. · 20161 recall
  • K142053Universal Clamp Spinal Fixation SystemZimmer Spine, Inc. · 2014
  • K133482Silc Fixation SystemGlobus Medical, Inc. · 2014
  • K132395LigapassMedicrea International · 2013

More from K2m, Inc.

100 FDA decisions under this applicant name. See the company

  • K260546Q Pedicle InstrumentsK2m, Inc. · 2026
  • K253545Vulcan Spinal SystemK2m, Inc. · 2026
  • K252873Q Interbody InstrumentsK2m, Inc. · 2026
  • K211320CAPRI Corpectomy Cage SystemK2m, Inc. · 2022
  • K202528Cannulated Power Driver AttachmentK2m, Inc. · 2020

Recent decisions in OWI

The OWI category page

  • K261374LigaPASS™ SystemMedicrea International S.A.S · 2026
  • K253615Invictus Bands SystemAlphatec Spine, Inc. · 2026
  • K222097OLYMPIC Deformity Band SystemAstura Medical · 2023
  • K230565HILINE™ Fixation SystemGlobus Medical, Inc. · 2023
  • K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA · 2022

https://510kreport.com/device/K143350 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143350: Nile Alternative Fixation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143350

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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