510(k) · Cleared
Recalled · Class II · 2019Hoffmann II External Fixation System Line Extension Model 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, Hoffmann II EX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · JEC Component, Traction, Invasive
Cleared on Jan 14, 2011 after a 106-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 14, 2011
- Review
- 106 days
- Class
- Class II
- Product code
- JEC
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK102885 Hoffmann II External Fixation System Line Extension Model…Stryker Corp. · 2011
- Descendant · cites it directly · 0 of its ownK163028 Medline ReNewal Reprocessed Stryker External Fixation DevicesSurgical Instrument Service and Savings, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K163028Medline ReNewal Reprocessed Stryker External Fixation DevicesSurgical Instrument Service and Savings, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K102885 | Hoffmann II External Fixation System Line Extension Model 4920-1-010… | Stryker Corp. | 2011 | — |
| +1 | K163028 | Medline ReNewal Reprocessed Stryker External Fixation Devices | Surgical Instrument Service and Savings, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 JEC? 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 JEC device
- #1 K193256 Anjon Bremer Halo Systemscore 3.2 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | — | Hoffmann II MRI System Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163028 | Medline ReNewal Reprocessed Stryker External Fixation Devices | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 21, 2019 | Class II | Z-0781-2020 | Under Investigation by firm | Pin To Rod Coupling could not clamp the pin and rod as intended |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K163028 (Surgical Instrument Service and Savings, Inc., 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JEC devicesJEC Component, Traction, Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JEC
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JEC
Too few JEC 510(k)s in any year since 2007 to give a median.
Recalls per year · JEC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEC
2in 2025
MAUDE reports naming product code JEC, 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 | 1 | — | 0 | 1 |
| 2008 | 1 | — | 1 | 9 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 1 | 8 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 2 | — | 1 | 2 |
| 2019 | 1 | — | 1 | 3 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Hoffmann II External Fixation System is intended to be used in the stabilization of
open and/or unstable fractures and where the soft tissue injury may preclude the use of
other fracture treatments such as IM rodding, casting and other mecans of internal fixation.
The indications for use of metallic external fixation devices include:
* Bone fracture fixation
* Osteotomy
* Arthrodesis
* Correction of deformity
* Revision procedures where other treatments or devices have been unsuccessful
* Bone reconstruction procedures
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/K102885 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102885: Hoffmann II External Fixation System Line Extension Model 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, Hoffmann II EX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102885
Report an extraction error
Are you the manufacturer?
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