510(k) · Cleared
ClearedPolarus Connect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acumed, LLC · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Cleared on Oct 10, 2013 as substantially equivalent to K051735 (Smith & Nephew, Inc., 2005) and 3 other predicates after a 128-day review. Its family tree reaches back 9 generations to 1984.
- Decided
- Oct 10, 2013
- Review
- 128 days
- Class
- Class II
- Product code
- LXT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K841189 (1984). 86 ancestors in all, the oldest K791619 (1979). No later device cites it as a predicate yet.
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations between
- 3 generations backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
- 2 generations backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
- 1 generation backK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- This deviceK131636 Polarus ConnectAcumed, LLC · 2013
Show all 9 generations
- Root · 9 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 7 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 6 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 3 generations backK043316 Rabea Spinal ImplantSignus Medizintechnik GmbH · 2005
- 2 generations backK052533 Kimba Spinal ImplantSignus Medizintechnik GmbH · 2005
- 1 generation backK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- This deviceK131636 Polarus ConnectAcumed, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −8 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −7 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −6 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −3 | K043316 | Rabea Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −2 | K052533 | Kimba Spinal Implant | Signus Medizintechnik GmbH | 2005 | — |
| −1 | K091425 | Quantum M Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2010 | — |
| 0 (this device) | K131636 | Polarus Connect | Acumed, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 9 | 0 |
| 2001 | 12 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2008 | 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 LXT? 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 LXT device
- #1 K230067 Para-Fix External Fixation Systemscore 6.3 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySummary page 1…inciples and material composition when compared to the predicate devices cleared under the following submissions: * K05 1735 Smith & Nephew PERI-LOC Locking Bone Plates and Locking Bone Screws for the upper extremity… | 2005 |
| * | K091425 | Quantum M Composite Nailing SystemSummary page 1…* K05 1735 Smith & Nephew PERI-LOC Locking Bone Plates and Locking Bone Screws for the upper extremity * K09 1425 NMB Medical Applications. Ltd Quantum IM Composite Nailing System… | 2010 |
| * | K012655 | Congruent Bone Plate SystemSummary page 2…109 K13 1636 Page 2 of 2 * K012655 Acumed Congruent Bone Plate System * K95 1740 Acumed Intrarnedullary Fixation Rod Predicate Devices:… | 2001 |
| * | K951740 | Intramedulary Fixation RodSummary page 2…K13 1636 Page 2 of 2 * K012655 Acumed Congruent Bone Plate System * K95 1740 Acumed Intrarnedullary Fixation Rod Predicate Devices: The subject device is substantially equivalent to previously cleared… | 1995 |
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 29 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 15 of the 86 ancestors have a recall of any class.
- 17 other devices also cite its predicate K051735.
How does its category compare?
All LXT devicesLXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LXT
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LXT
Too few LXT 510(k)s in any year since 2007 to give a median.
Recalls per year · LXT
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXT
7in 2025
MAUDE reports naming product code LXT, 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 | — | 1 | 26 |
| 2008 | 1 | — | 0 | 58 |
| 2009 | 1 | — | 7 | 41 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 1 | — | 0 | 85 |
| 2012 | 0 | — | 0 | 42 |
| 2013 | 2 | — | 0 | 39 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 0 | 35 |
| 2016 | 0 | — | 0 | 38 |
| 2017 | 0 | — | 0 | 66 |
| 2018 | 0 | — | 2 | 73 |
| 2019 | 0 | — | 0 | 40 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 21 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 27 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Acumed Polarus® Connect System includes plates, nails, screws and accessories designed to address fractures, fusions, and osteotomies of the humerus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131636: Polarus Connect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131636
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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