510(k) Report

510(k) · Cleared

Cleared

PK High Tibial Osteotomy Correction System

K182285510(k) TraditionalCleared Jun 20, 2019301-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

Paonan Biotech Co., Ltd. · KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

Cleared on Jun 20, 2019 as substantially equivalent to K971272 (Trend Medical, Inc., 1997) and 4 other predicates after a 301-day review. Its family tree reaches back 3 generations to 2005.

Decided
Jun 20, 2019
Review
301 days
Class
Class II
Product code
KTW
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K051306 (2005). 9 ancestors in all, the oldest K831576 (1983). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2012: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor2006: 1 other ancestor2005: 1 other ancestor1983: 1 other ancestorK051306 · Hoffmann II Mri External Fixation System · Howmedica Osteonics Corp. · 2005K111786 · Hoffmann 3 Modular External Fixation System · Stryker Corp. · 2012K121252 · Hoffmann 3 Modular External Fixation System · Stryker Corp. · 201219801990200020102020
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors K121252 · Hoffmann 3 Modular External Fixation System · Stryker Corp. · 2012K111786 · Hoffmann 3 Modular External Fixation System · Stryker Corp. · 2012K051306 · Hoffmann II Mri External Fixation System · Howmedica Osteonics Corp. · 20050
  1. Root · 3 generations backK051306 Hoffmann II Mri External Fixation SystemHowmedica Osteonics Corp. · 2005
  2. 2 generations backK111786 Hoffmann 3 Modular External Fixation SystemStryker Corp. · 2012
  3. 1 generation backK121252 Hoffmann 3 Modular External Fixation SystemStryker Corp. · 2012
  4. This deviceK182285 PK High Tibial Osteotomy Correction SystemPaonan Biotech Co., Ltd. · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K051306Hoffmann II Mri External Fixation SystemHowmedica Osteonics Corp.2005—
−2K111786Hoffmann 3 Modular External Fixation SystemStryker Corp.2012—
−1K121252Hoffmann 3 Modular External Fixation SystemStryker Corp.2012—
0 (this device)K182285PK High Tibial Osteotomy Correction SystemPaonan Biotech Co., Ltd.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199610
199710
200510
200610
201210
FIG. 1 — Lineage of K182285, 2005–2019Source: 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.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (5)

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
*K971272Trauma-Fix External Fixator
Summary page 4
…sories (21 CFR 888.3030) Device Class: Class II Panel: Orthopedic Product Code: KTW, KTT, JDW Predicate Devices: Primary predicate device: TRAUMA-FIX EXTERNAL FIXATOR (K971272) Additional predicates: HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM (K111786, K121252, K122284) ORTHOFIX MODULSYSTEM (K955848) K…
Trend Medical, Inc.1997—
*K111786Hoffmann 3 Modular External Fixation System
Summary page 4
…ode: KTW, KTT, JDW Predicate Devices: Primary predicate device: TRAUMA-FIX EXTERNAL FIXATOR (K971272) Additional predicates: HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM (K111786, K121252, K122284) ORTHOFIX MODULSYSTEM (K955848) K182285 Page 1 of 3 Paonan Biotech Co., Ltd. PK High Tibial Os…
Stryker Corp.2012—
*K121252Hoffmann 3 Modular External Fixation System
Summary page 4
…KTT, JDW Predicate Devices: Primary predicate device: TRAUMA-FIX EXTERNAL FIXATOR (K971272) Additional predicates: HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM (K111786, K121252, K122284) ORTHOFIX MODULSYSTEM (K955848) K182285 Page 1 of 3 Paonan Biotech Co., Ltd. PK High Tibial Osteotomy C…
Stryker Corp.2012—
*K122284Hoffmann 3
Summary page 4
…Predicate Devices: Primary predicate device: TRAUMA-FIX EXTERNAL FIXATOR (K971272) Additional predicates: HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM (K111786, K121252, K122284) ORTHOFIX MODULSYSTEM (K955848) K182285 Page 1 of 3 Paonan Biotech Co., Ltd. PK High Tibial Osteotomy Correction…
Stryker Corp.2012—
*K955848Orthofix Modulsystem
Summary page 4
…dicate device: TRAUMA-FIX EXTERNAL FIXATOR (K971272) Additional predicates: HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM (K111786, K121252, K122284) ORTHOFIX MODULSYSTEM (K955848) K182285 Page 1 of 3 Paonan Biotech Co., Ltd. PK High Tibial Osteotomy Correction System Traditional 510(K) Dev…
Orthofix, Inc.199623

What descends from it?

No later submission names this one as a predicate yet.

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 14 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
  • 1 of the 9 ancestors has a recall of any class.

How does its category compare?

All KTW devices

KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · KTW

1in 2019

2008: 22012: 12016: 12017: 22019: 1
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTW

Too few KTW 510(k)s in any year since 2007 to give a median.

Recalls per year · KTW

57in 2010

2010: 57
2007high 57 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KTW

96in 2025

2007: 32008: 102009: 22010: 262011: 212012: 702013: 702014: 622015: 262016: 412017: 272018: 242019: 112020: 602021: 252022: 502023: 302024: 1232025: 96
2007high 123 (2024) · low 2 (2009)2025

MAUDE reports naming product code KTW, 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—03
20082—010
20090—02
20100—5726
20110—021
20121—070
20130—070
20140—062
20150—026
20161—041
20172—027
20180—024
20191—011
20200—060
20210—025
20220—050
20230—030
20240—0123
20250—096
20260—0—

What is it indicated for?

The PK High Tibial Osteotomy Correction System is an external fixation device, which is intended for use in the treatment of the following indications in the tibia:

- Temporary fracture fixation

- Correction of deformity

- Osteotomy

- Bone union

- Bone reconstruction

- Fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality

- Leg lengthening

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

More from Paonan Biotech Co., Ltd.

6 FDA decisions under this applicant name. See the company

  • K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd. · 2023
  • K180230NEST Interbody SystemPaonan Biotech Co., Ltd. · 2019
  • K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd. · 2019
  • K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd. · 2018
  • K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd. · 2017

Recent decisions in KTW

The KTW category page

  • K171606AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. (Aos) · 2017
  • K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017
  • K160409AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. · 2016
  • K122541Orthofix Contours Proimal Humeral Plate (PHP)Orthofix Srl · 2012
  • K080590Aos Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. · 2008

https://510kreport.com/device/K182285 · printed Nov 4, 2026

Cite this page

510(k) Report. “K182285: PK High Tibial Osteotomy Correction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182285

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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