510(k) Report

510(k) · Cleared

Cleared

Hoffmann LRF (Limb Reconstruction Frame System)

K130334510(k) TraditionalCleared May 3, 201381-day reviewClass II21 CFR 888.3030

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

Stryker Trauma AG · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on May 3, 2013 as substantially equivalent to K113327 (Stryker Corp., 2012) and 1 other predicate after an 81-day review. Its family tree reaches back 3 generations to 2000. 15 later devices descend from it.

Decided
May 3, 2013
Review
81 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K994143 (2000). 5 ancestors in all. 15 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2000: 1 other ancestor2014: 1 descendant cleared2016: 2 descendants cleared2017: 1 descendant cleared2020: 1 descendant cleared2019: 1 descendant cleared2021: 2 descendants cleared2023: 2 descendants cleared2025: 4 descendants cleared2026: 1 descendant clearedK994143 · Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories] · Smith & Nephew, Inc. · 2000 · recalledK031181 · External Fixation Systems · Smith & Nephew, Inc. · 2003K113327 · Hoffmann LRF (Limb Reconstruction Frame) System · Stryker Corp. · 2012 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 2 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant7 generations forward: 2 descendants8 generations forward: 3 descendants9 generations forward: 2 descendants10 generations forward: 1 descendant K113327 · Hoffmann LRF (Limb Reconstruction Frame) System · Stryker Corp. · 2012 · recalledK031181 · External Fixation Systems · Smith & Nephew, Inc. · 2003K994143 · Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories] · Smith & Nephew, Inc. · 2000 · recalled0+5+10
  1. Root · 3 generations backK994143 Smith & Nephew External Fixation System [Unilateral (Linear) &…Smith & Nephew, Inc. · 2000 · Recalled
  2. 2 generations backK031181 External Fixation SystemsSmith & Nephew, Inc. · 2003
  3. 1 generation backK113327 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Corp. · 2012 · Recalled
  4. This deviceK130334 Hoffmann LRF (Limb Reconstruction Frame System)Stryker Trauma AG · 2013
  5. Descendant · cites it directly · 14 of its ownK140961 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2014
  6. Descendant · 2 generations on · 13 of its ownK153377 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH · 2016 · Recalled
  7. Descendant · 3 generations on · 12 of its ownK161753 Hoffman LRF SystemStryker GmbH · 2016
  8. Descendant · 4 generations on · 11 of its ownK163656 Hoffmann LRF SystemStryker GmbH · 2017 · Recalled
  9. Descendant · 5 generations on · 10 of its ownK182968 Hoffmann LRF SystemStryker GmbH · 2019

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2014: 12016: 22017: 12019: 12020: 12021: 22023: 22025: 42026: 1
2014high 4 (2025) · low 0 (2015)2026

Most influential descendants

Showing 5 of 15 · See all
  • K140961Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2014 · cites it directly14descendants
  • K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH · 2016 · 2 generations on13descendants
  • K161753Hoffman LRF SystemStryker GmbH · 2016 · 3 generations on12descendants
  • K163656Hoffmann LRF SystemStryker GmbH · 2017 · 4 generations on11descendants
  • K182968Hoffmann LRF SystemStryker GmbH · 2019 · 5 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K994143Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral…Smith & Nephew, Inc.200019
−2K031181External Fixation SystemsSmith & Nephew, Inc.2003—
−1K113327Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Corp.20123
0 (this device)K130334Hoffmann LRF (Limb Reconstruction Frame System)Stryker Trauma AG2013—
+1K140961Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG2014—
+2K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH20162
+3K161753Hoffman LRF SystemStryker GmbH2016—
+4K163656Hoffmann LRF SystemStryker GmbH20175
+5K182968Hoffmann LRF SystemStryker GmbH2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201620
201710
201910
202010
202120
202320
202540
202610
FIG. 1 — Lineage of K130334, 2000–2026Source: 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.

Planning a device in KTT? 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 KTT device

  1. #1 K242861 TrueLok Elevatescore 21.3 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (2)

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
*K113327Hoffmann LRF (Limb Reconstruction Frame) System
Summary page 2
…lly equivalent in intended, use, materials and performance characteristics to the following predicate devices: * Hloffmann LRF (Limb Reconstruction Frame) System- K1 13327 * Ilizarov External Fixation System (K031 181I-Smith and Nephew) Page 2/3…
Stryker Corp.20123
*K031181External Fixation Systems
Summary page 2
…rmance characteristics to the following predicate devices: * Hloffmann LRF (Limb Reconstruction Frame) System- K1 13327 * Ilizarov External Fixation System (K031 181I-Smith and Nephew) Page 2/3…
Smith & Nephew, Inc.2003—

Also cleared against K113327: 2 other devices →

What descends from it? (15)

See all 15

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140961Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG201414

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 13 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
  • 3 of the 5 ancestors have a recall of any class.
  • Of its descendants, K140961 (Stryker Trauma AG, 2014) has gone furthest, with 14 descendants of its own.
  • 2 other devices also cite its predicate K113327.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · KTT

10in 2025

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

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

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
2007high 14 (2018) · low 0 (2011)2026

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

Adverse event reports per year · KTT

673in 2025

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, 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
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—

What is it indicated for?

The Stryker Hoffrnann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of: * Open and Closed Fractures * Post-traumatic joint contracture which has resulted in loss of range of motion * Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction * Pseudoarthrosis or non-union of long bones * Limb lengthening by…

Read the full statement (146 words)

The Stryker Hoffrnann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of:

* Open and Closed Fractures

* Post-traumatic joint contracture which has resulted in loss of range of motion

* Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction

* Pseudoarthrosis or non-union of long bones

* Limb lengthening by epiphyseal or metaphyseal distraction

* Correction of bony or soft tissue deformity

* Correction of segmental bony or soft tissue defects

* Joint arthrodesis

* Management of comminuted intra-articular fractures of the distal radius

The Stryker Hoffhmann LRF System is indicated in adults for:

* Osteotomy

* Revision procedure where other treatments or devices have been unsuccessful

* Bone reconstruction procedures

* Fusions and replantations of the foot

* Charcot foot reconstruction

* Lisfranc dislocations

Indications for use as stated in the FDA summary.

Also cleared against K113327

2 other devices cite the same predicate.

  • K140961Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2014
  • K130907Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2013

More from Stryker Trauma AG

25 FDA decisions under this applicant name. See the company

  • K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total…Stryker Trauma AG · 2017
  • K153154Asnis JFX SystemStryker Trauma AG · 2015
  • K151178VariAx 2 Wrist Fusion SystemStryker Trauma AG · 2015
  • K143138AxSOS 3 Ti Locking Plate SystemStryker Trauma AG · 2014
  • K140961Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2014

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https://510kreport.com/device/K130334 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130334: Hoffmann LRF (Limb Reconstruction Frame System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130334

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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