510(k) · Cleared
ClearedExternal Remote Controller ERC 4P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive Specialized Orthopedics, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Dec 22, 2020 as substantially equivalent to K191336 (Nuvasive Specialized Orthopedics, Inc., 2019) and 3 other predicates after a 126-day review. Its family tree reaches back 12 generations to 1983.
- Decided
- Dec 22, 2020
- Review
- 126 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K831576 (1983). 106 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 8 generations between
- 3 generations backK160325 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2016
- 2 generations backK170169 PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2017
- 1 generation backK191336 PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2019
- This deviceK202348 External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc. · 2020
Show all 12 generations
- Root · 12 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 11 generations backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
- 10 generations backK010322 Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 2001 · Recalled
- 9 generations backK031219 Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc. · 2003 · Recalled
- 8 generations backK101997 Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2011 · Recalled
- 7 generations backK131677 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
- 6 generations backK133289 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
- 5 generations backK141023 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014
- 4 generations backK151131 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated · 2015 · Recalled
- 3 generations backK160325 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2016
- 2 generations backK170169 PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2017
- 1 generation backK191336 PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2019
- This deviceK202348 External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −11 | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | 23 |
| −10 | K010322 | Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthodyne, Inc. | 2001 | 1 |
| −9 | K031219 | Modification to Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthofix, Inc. | 2003 | 1 |
| −8 | K101997 | Ellipse Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2011 | 2 |
| −7 | K131677 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2013 | — |
| −6 | K133289 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2013 | — |
| −5 | K141023 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2014 | — |
| −4 | K151131 | PRECICE Intramedullary Limb Lengthening System | Ellipse Technologies, Incorporated | 2015 | 2 |
| −3 | K160325 | PRECICE Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2016 | — |
| −2 | K170169 | PRECICE Intramedullary Limb Lengthening System | Nuvasive Specialized Orthopedics, Inc. | 2017 | — |
| −1 | K191336 | PRECICE System | Nuvasive Specialized Orthopedics, Inc. | 2019 | — |
| 0 (this device) | K202348 | External Remote Controller ERC 4P | Nuvasive Specialized Orthopedics, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 6 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 HSB? 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 HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K191336 | PRECICE SystemSummary page 4…KTT, HWC, HRS C. Predicate Devices The subject External Remote Controller ERC 4P is substantially equivalent to the primary predicate device, Precice System (K191336), and additional predicate devices Precice Intramedullary Limb Lengthening System (K113219) Precice Plating System (K192181) a… | 2019 |
| * | K113219 | Ellipse Precice Intramedullary Limb Lengthening SystemSummary page 4…ubstantially equivalent to the primary predicate device, Precice System (K191336), and additional predicate devices Precice Intramedullary Limb Lengthening System (K113219) Precice Plating System (K192181) and Precice Ankle Salvage System (K200430). D. Device Description The fourth generation… | 2012 |
| * | K192181 | PRECICE Plating SystemSummary page 4…imary predicate device, Precice System (K191336), and additional predicate devices Precice Intramedullary Limb Lengthening System (K113219) Precice Plating System (K192181) and Precice Ankle Salvage System (K200430). D. Device Description The fourth generation External Remote Controller ERC 4… | 2019 |
| * | K200430 | Precice® Ankle Salvage System Cleared while this submission was under review Summary page 4…1336), and additional predicate devices Precice Intramedullary Limb Lengthening System (K113219) Precice Plating System (K192181) and Precice Ankle Salvage System (K200430). D. Device Description The fourth generation External Remote Controller ERC 4P is a portable hand-held system used to no… | 2020 |
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 37 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 27 of the 106 ancestors have a recall of any class.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, 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 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
The Precice® System (inclusive of Precice, Precice Stryde, and Precice Bone Transport) is indicated for limb-lengthening, open and closed fracture fixation, pseudarthrosis, mal-unions, non-unions or bone transport of long bones. The Precice® Plating System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones in pediatrics and small stature adult patients. The Precice® Ankle Salvage…
Read the full statement (116 words)
The Precice® System (inclusive of Precice, Precice Stryde, and Precice Bone Transport) is indicated for limb-lengthening, open and closed fracture fixation, pseudarthrosis, mal-unions, non-unions or bone transport of long bones.
The Precice® Plating System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones in pediatrics and small stature adult patients.
The Precice® Ankle Salvage System is intended for tibio-talo-calcaneal fusions. When used for TTC fusion, the Precice Ankle Salvage System may be used for open and closed fracture fixation, pseudarthrosis, mal-unions, non-unions, or bone transport of long bones adjacent to the fusion site. The device may be used for subsequent limb lengthening once tibio-talo-calcaneal fusion has been achieved.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202348: External Remote Controller ERC 4P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202348
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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