510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Synthes Mirs

K113044510(k) TraditionalCleared Dec 21, 201170-day reviewClass II21 CFR 888.3070Recalls 3

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

Synthes Spine · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Dec 21, 2011 as substantially equivalent to K963045 (Synthes (Usa), 1997) and 13 other predicates after a 70-day review. Its family tree reaches back 7 generations to 1995. 1 of the 169 devices in its family, counting itself, has a Class I recall. 93 later devices descend from it. It has been recalled 3 times.

Decided
Dec 21, 2011
Review
70 days
Class
Class II
Product code
NKB
Recalls
3
Predicates
14

Its longest line of descent runs back 7 generations to K950697 (1995). 75 ancestors in all, the oldest K781443 (1978). 93 later devices descend from it, 3 citing it directly. 1 of the 169 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2011: 2 other ancestors2010: 4 other ancestors, 1 with a Class I recall12009: 2 other ancestors2008: 5 other ancestors2007: 5 other ancestors2004: 6 other ancestors2003: 8 other ancestors2000: 6 other ancestors1997: 3 other ancestors2006: 2 other ancestors2005: 4 other ancestors2002: 4 other ancestors2001: 6 other ancestors1999: 2 other ancestors1998: 2 other ancestors1994: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestor1996: 3 other ancestors1978: 1 other ancestor2012: 4 descendants cleared2014: 3 descendants cleared2017: 12 descendants cleared2018: 4 descendants cleared2021: 7 descendants cleared2016: 3 descendants cleared2015: 5 descendants cleared2024: 12 descendants cleared2019: 5 descendants cleared2020: 6 descendants cleared2025: 9 descendants cleared2023: 9 descendants cleared2022: 6 descendants cleared2026: 8 descendants 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) K082942 · Modfication to: Expedium Spine System · Depuy Spine, Inc. · 2008K090648 · Viper 2 System · Depuy Spine, Inc. · 200919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 13 other ancestors, 1 with a Class I recall12 generations back: 23 other ancestors3 generations back: 13 other ancestors4 generations back: 12 other ancestors5 generations back: 3 other ancestors6 generations back: 3 other ancestors7 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 12 descendants3 generations forward: 11 descendants4 generations forward: 16 descendants5 generations forward: 16 descendants6 generations forward: 13 descendants7 generations forward: 12 descendants8 generations forward: 7 descendants9 generations forward: 3 descendants K090648 · Viper 2 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+5
  1. Root · 7 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
  2. 6 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
  3. 5 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
  4. 4 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
  5. 3 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
  6. 2 generations backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
  7. 1 generation backK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
  8. This deviceK113044 Synthes MirsSynthes Spine · 2011
  9. Descendant · cites it directly · 74 of its ownK120571 Synthes Uss ConnectorSynthes Spine · 2012
  10. Descendant · 2 generations on · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
  11. Descendant · 3 generations on · 30 of its ownK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
  12. Descendant · 4 generations on · 26 of its ownK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
  13. Descendant · 5 generations on · 21 of its ownK173130 Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017

Showing 5 of 93 descendants. See all descendants

Descendants cleared per year

2012: 42014: 32015: 52016: 32017: 122018: 42019: 52020: 62021: 72022: 62023: 92024: 122025: 92026: 8
2012high 12 (2017) · low 0 (2013)2026

Class I recalls in this family

  • K100952 Modification to Synthes Matrix Systemdirect predicate · 2010

Most influential descendants

Showing 5 of 93 · See all
  • K120571Synthes Uss ConnectorSynthes Spine · 2012 · cites it directly74descendants
  • K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 2 generations on67descendants
  • K143248Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014 · 3 generations on30descendants
  • K150856Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015 · 4 generations on26descendants
  • K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017 · 5 generations on21descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K950697Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech1995—
−6K050461Xia 4.5 Spinal SystemStryker Spine2005—
−5K052761Modification to: Xia 4.5 Spinal SystemStryker Spine2005—
−4K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine20061
−3K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006—
−2K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008—
−1K090648Viper 2 SystemDepuy Spine, Inc.2009—
0 (this device)K113044Synthes MirsSynthes Spine2011—
+1K120571Synthes Uss ConnectorSynthes Spine2012—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)20141
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.2014—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.2015—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
199310
199410
199510
199630
199730
199820
199920
200060
200160
200240
200380
200460
200540
200620
200750
200850
200920
201041
201120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201240
201430
201550
201630
2017120
201840
201950
202060
202170
202260
202390
2024120
202590
202680
FIG. 1 — Lineage of K113044, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

1 device in this family has a Class I recall. 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? (14)

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
*K963045Synthes (U.S.a.) Universal Sacral System
Summary page 1
…Orthopaedic and Rehabilitation Devices Panel Product Code: NKB, MNH, MNI, KWQ, KWP Predicates: Synthes UISS, K963045 DePuy Viper 2, K090648 Synthes Click'X, K992739 Abbott Spine Pathfin…
Synthes (Usa)1997—
*K090648Viper 2 System
Summary page 1
…abilitation Devices Panel Product Code: NKB, MNH, MNI, KWQ, KWP Predicates: Synthes UISS, K963045 DePuy Viper 2, K090648 Synthes Click'X, K992739 Abbott Spine Pathfinder, K030625 Synthe…
Depuy Spine, Inc.2009—
*K992739Click'x
Summary page 1
…Product Code: NKB, MNH, MNI, KWQ, KWP Predicates: Synthes UISS, K963045 DePuy Viper 2, K090648 Synthes Click'X, K992739 Abbott Spine Pathfinder, K030625 Synthes Click'X, K031 175 Abbott Spine…
Synthes Spine20001
*K030625Spinal Concepts Inc. Pathfinder
Summary page 1
…: Synthes UISS, K963045 DePuy Viper 2, K090648 Synthes Click'X, K992739 Abbott Spine Pathfinder, K030625 Synthes Click'X, K031 175 Abbott Spine Pathfinder, K071 174 Synth…
Spinal Concepts, Inc.20036
*K031175Click'x Monoaxial Screws and Hooks
Summary page 1
…DePuy Viper 2, K090648 Synthes Click'X, K992739 Abbott Spine Pathfinder, K030625 Synthes Click'X, K031 175 Abbott Spine Pathfinder, K071 174 Synthes UISS Illiosacral and Polyaxial, DePuy Expedium,…
Synthes (Usa)2003—
*K071174Pathfinder System Polyaxial Pedicle Screws
Summary page 1
…Synthes Click'X, K992739 Abbott Spine Pathfinder, K030625 Synthes Click'X, K031 175 Abbott Spine Pathfinder, K071 174 Synthes UISS Illiosacral and Polyaxial, DePuy Expedium, K041119 K<082572…
Abbott Spine, Inc.20074
*K082572Uss Iliosacral, Uss Polyaxial
Summary page 1
…175 Abbott Spine Pathfinder, K071 174 Synthes UISS Illiosacral and Polyaxial, DePuy Expedium, K041119 K<082572 Medtronic CID Horizon, K1 11457 Synthes Matrix System, K<092929…
Synthes Spine2008—
*K041119Expedium Spine System
Summary page 1
…Synthes Click'X, K031 175 Abbott Spine Pathfinder, K071 174 Synthes UISS Illiosacral and Polyaxial, DePuy Expedium, K041119 K<082572 Medtronic CID Horizon, K1 11457 Synthes…
Depuy Spine, Inc.2004—
*K111457CD Horizon Spinal System
Summary page 1
…Synthes UISS Illiosacral and Polyaxial, DePuy Expedium, K041119 K<082572 Medtronic CID Horizon, K1 11457 Synthes Matrix System, K<092929 Synthes Matrix System, K<093668…
Medtronic Sofamor Danek2011—
*K092929Synthes Matrix System
Summary page 1
…ePuy Expedium, K041119 K<082572 Medtronic CID Horizon, K1 11457 Synthes Matrix System, K<092929 Synthes Matrix System, K<093668 Synthes Matrix System, 1100952…
Synthes (Usa)20091
*K093668Synthes Matrix Mis Rods
Summary page 1
…2 Medtronic CID Horizon, K1 11457 Synthes Matrix System, K<092929 Synthes Matrix System, K<093668 Synthes Matrix System, 1100952 Synthes Matrix System, 1100634…
Synthes (Usa)2010—
*K100952Modification to Synthes Matrix System
Summary page 1
…K1 11457 Synthes Matrix System, K<092929 Synthes Matrix System, K<093668 Synthes Matrix System, 1100952 Synthes Matrix System, 1100634 Synthes 6.0 CoCr and CP Ti-3 Rods,…
Synthes Spine2010Class I
*K100634Synthes Matrix System
Summary page 1
…, K<092929 Synthes Matrix System, K<093668 Synthes Matrix System, 1100952 Synthes Matrix System, 1100634 Synthes 6.0 CoCr and CP Ti-3 Rods, K<103287 Device Synthes MIR…
Synthes (Usa)2010—
*K103287Synthes 6.0 Cocr and CPT TI-3 Rods
Summary page 1
…thes Matrix System, 1100952 Synthes Matrix System, 1100634 Synthes 6.0 CoCr and CP Ti-3 Rods, K<103287 Device Synthes MIRS isan addition to Synthes' existing non-cervical spinal fixation Description: devi…
Synthes Spine2011—

Also cleared against K963045: 10 other devices →

What descends from it? (93)

See all 93

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

NumberDeviceApplicantDecidedDescendants
K120571Synthes Uss ConnectorSynthes Spine201274
K120838Synthes Matrix SystemSynthes Spine201216
K120928Synthes Matrix SystemSynthes Spine20120

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 7, 2012Class IIZ-0395-2014Use errorThis action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the…
Sep 7, 2012Class IIZ-0396-2014Use errorThis action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the…
Jun 18, 2012Class IIZ-0001-2013Labeling designSynthes is initiating a Medical Device Labeling Correction following a detailed review of the current labeling in response to reported complaints. Synthes has identified technique measures and has updated the labeling associated with this…

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 7 months on median.
  • 10 of the 75 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K120571 (Synthes Spine, 2012) has gone furthest, with 74 descendants of its own.
  • 10 other devices also cite its predicate K963045.

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. 2011, 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 Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-52/ilium), posterior hook fixation (TI1-5), or anterolateral fixation (T8I-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc…

Read the full statement (374 words)

The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-52/ilium), posterior hook fixation (TI1-5), or anterolateral fixation (T8I-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of 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), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).

When treating patients with Degenerative Disc Disease (ODD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5 mm/6.Omm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.Omm parallel connectors, the Synthes Small Stature UISS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.Ommn parallel connectors, the Synthes Small Stature USS can be linked to the Synthes UISS 6.0 mm rod systems.

When used with the 3.5 mm/6.Omm and 4.0 mmI6.Omm tapered rods, the Synthes USS 6.0mmn rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.Smm and 4.0 mmIS.5 mm tapered rods, Matrix or MIRS can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.Omm tapered rods, the Synthes UISS 6.0 mim rod systems can be linked to the Matrix System or MIRS.

In addition, Synthes USS 6.0 min rod systems can be interchanged with all UISS 6.0 mm rods and transconnectors except Synthes 6.0 mim cobalt-chromium-molybdenumn alloy and titanium grade 3 rods, which can only be used with Pangea.

Synthes USS

o 6.0 mmn Rod Systems: USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix

o 5.5 mm Rod System: Matrix, MIRS

o 5.0 mm Rod System: UISS Small Stature

CerviFix

o 3.5 mim Rod Systems: CerviFix, Axon, Synapse

o 4.0 mm Rod System: Synapse

Indications for use as stated in the FDA summary.

Also cleared against K963045

10 other devices cite the same predicate.

  • K120838Synthes Matrix SystemSynthes Spine · 2012
  • K120928Synthes Matrix SystemSynthes Spine · 2012
  • K120571Synthes Uss ConnectorSynthes Spine · 2012
  • K113149Synthes Uss ConnectorsSynthes Spine · 2012
  • K103287Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine · 2011
  • K100952Modification to Synthes Matrix SystemSynthes Spine · 20101 Class I recall

More from Synthes Spine

36 FDA decisions under this applicant name. See the company

  • K122211Synthes Navigable Pedicle Preparation InstrumentsSynthes Spine · 2012
  • K120838Synthes Matrix SystemSynthes Spine · 2012
  • K111048Synthes Scout Tack FixationSynthes Spine · 2012
  • K120928Synthes Matrix SystemSynthes Spine · 2012
  • K120571Synthes Uss ConnectorSynthes Spine · 2012

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/K113044 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113044: Synthes Mirs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113044

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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