510(k) · Cleared
ClearedParagon 28 External Ring Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon 28, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Nov 8, 2021 as substantially equivalent to K203568 (Stryker GmbH, 2021) after a 59-day review. Its family tree reaches back 10 generations to 2000. 5 later devices descend from it.
- Decided
- Nov 8, 2021
- Review
- 59 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K994143 (2000). 14 ancestors in all, the oldest K970748 (1997). 5 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK994143 Smith & Nephew External Fixation System [Unilateral (Linear) &…Smith & Nephew, Inc. · 2000 · Recalled
- 6 generations between
- 3 generations backK163656 Hoffmann LRF SystemStryker GmbH · 2017 · Recalled
- 2 generations backK182968 Hoffmann LRF SystemStryker GmbH · 2019
- 1 generation backK203568 Hoffmann LRF SystemStryker GmbH · 2021
- This deviceK212895 Paragon 28 External Ring Fixation SystemParagon 28, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK232838 Monkey RingsTM External Fixation SystemParagon 28, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK241563 Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK253291 Excelsior SystemBlue Ocean Global · 2026
- Descendant · cites it directly · 0 of its ownK253613 Monkey Rings External Ring Fixation SystemParagon 28, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK251128 Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025
Show all 10 generations
- Root · 10 generations backK994143 Smith & Nephew External Fixation System [Unilateral (Linear) &…Smith & Nephew, Inc. · 2000 · Recalled
- 9 generations backK031181 External Fixation SystemsSmith & Nephew, Inc. · 2003
- 8 generations backK113327 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Corp. · 2012 · Recalled
- 7 generations backK130334 Hoffmann LRF (Limb Reconstruction Frame System)Stryker Trauma AG · 2013
- 6 generations backK140961 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2014
- 5 generations backK153377 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH · 2016 · Recalled
- 4 generations backK161753 Hoffman LRF SystemStryker GmbH · 2016
- 3 generations backK163656 Hoffmann LRF SystemStryker GmbH · 2017 · Recalled
- 2 generations backK182968 Hoffmann LRF SystemStryker GmbH · 2019
- 1 generation backK203568 Hoffmann LRF SystemStryker GmbH · 2021
- This deviceK212895 Paragon 28 External Ring Fixation SystemParagon 28, Inc. · 2021
Most influential descendants
Showing 5 of 5 · See all- K232838Monkey RingsTM External Fixation SystemParagon 28, Inc. · 2023 · cites it directly3descendants
- K241563Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025 · 2 generations on1descendant
- K253291Excelsior SystemBlue Ocean Global · 2026 · 2 generations on0descendants
- K253613Monkey Rings External Ring Fixation SystemParagon 28, Inc. · 2025 · cites it directly0descendants
- K251128Extremity Medical External Fixation SystemExtremity Medical, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K994143 | Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral… | Smith & Nephew, Inc. | 2000 | 19 |
| −9 | K031181 | External Fixation Systems | Smith & Nephew, Inc. | 2003 | — |
| −8 | K113327 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker Corp. | 2012 | 3 |
| −7 | K130334 | Hoffmann LRF (Limb Reconstruction Frame System) | Stryker Trauma AG | 2013 | — |
| −6 | K140961 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker Trauma AG | 2014 | — |
| −5 | K153377 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker GmbH | 2016 | 2 |
| −4 | K161753 | Hoffman LRF System | Stryker GmbH | 2016 | — |
| −3 | K163656 | Hoffmann LRF System | Stryker GmbH | 2017 | 5 |
| −2 | K182968 | Hoffmann LRF System | Stryker GmbH | 2019 | — |
| −1 | K203568 | Hoffmann LRF System | Stryker GmbH | 2021 | — |
| 0 (this device) | K212895 | Paragon 28 External Ring Fixation System | Paragon 28, Inc. | 2021 | — |
| +1 | K232838 | Monkey RingsTM External Fixation System | Paragon 28, Inc. | 2023 | — |
| +2 | K241563 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025 | — |
| +2 | K253291 | Excelsior System | Blue Ocean Global | 2026 | — |
| +1 | K253613 | Monkey Rings External Ring Fixation System | Paragon 28, Inc. | 2025 | — |
| +3 | K251128 | Extremity Medical External Fixation System | Extremity Medical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
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 K242861 TrueLok Elevatescore 21.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203568 | Hoffmann LRF SystemSummary page 5…vices Device Name(s) Manufacturer K-Number Hoffmann LRF System Stryker K203568 Reference Predicate Device: Table 3: Reference Predicate Devices Device Name(s)… | 2021 |
| † | K071394 | Modification to:Sbi Ringfix | 2007 |
| † | K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction System | 2016 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 14 ancestors have a recall of any class.
- Of its descendants, K232838 (Paragon 28, Inc., 2023) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K203568.
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
The Paragon 28 External Ring Fixation 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, infected union, non-union, or malunion of long bones * Limb…
Read the full statement (173 words)
The Paragon 28 External Ring Fixation 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, infected union, non-union, or malunion of long bones
* Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
* Correction of bony or soft tissue deformity (e.g. orthoplastic surgery)
* Correction of segmental bony or soft tissue defects
* Joint arthrodesis
* Management of comminuted intra-articular fractures
* Bone transport
The Paragon 28 External Ring Fixation 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
* Offloading and/or immobilization of ulcers and/or wounds of the foot and ankle
* Lisfranc dislocations
* Ankle distraction (arthrodiastasis)
* Septic fusion
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212895 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212895: Paragon 28 External Ring Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212895
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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