510(k) · Cleared
ClearedLifenet System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physio-Control, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Jan 12, 2010 as substantially equivalent to K073509 (Smith & Nephew, Inc., 2008) after a 21-day review. Its family tree reaches back 3 generations to 1997. 8 later devices descend from it.
- Decided
- Jan 12, 2010
- Review
- 21 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K971723 (1997). 4 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK971723 Fastak Suture Anchor (11.7MM)/(7.5MM)Arthrex, Inc. · 1997
- 2 generations backK051219 PushlockArthrex, Inc. · 2005
- 1 generation backK073509 Twinfix PK FP Suture AnchorSmith & Nephew, Inc. · 2008
- This deviceK093925 Lifenet SystemPhysio-Control, Inc. · 2010
- Descendant · cites it directly · 7 of its ownK102757 Lifenet SystemPhysio-Control, Inc. · 2010
- Descendant · 2 generations on · 5 of its ownK111296 Zoll RescuenetlinkZoll Medical Corporation, World Wide Headquarters · 2011
- Descendant · 3 generations on · 2 of its ownK141774 Zoll X SeriesZOLL Medical Corporation · 2014
- Descendant · 4 generations on · 1 of its ownK202375 ZOLL Propaq MZOLL Medical Corporation · 2021
- Descendant · 3 generations on · 1 of its ownK133484 Zoll X SeriesZoll Medical Corp · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K102757Lifenet SystemPhysio-Control, Inc. · 2010 · cites it directly7descendants
- K111296Zoll RescuenetlinkZoll Medical Corporation, World Wide Headquarters · 2011 · 2 generations on5descendants
- K141774Zoll X SeriesZOLL Medical Corporation · 2014 · 3 generations on2descendants
- K202375ZOLL Propaq MZOLL Medical Corporation · 2021 · 4 generations on1descendant
- K133484Zoll X SeriesZoll Medical Corp · 2014 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971723 | Fastak Suture Anchor (11.7MM)/(7.5MM) | Arthrex, Inc. | 1997 | — |
| −2 | K051219 | Pushlock | Arthrex, Inc. | 2005 | — |
| −1 | K073509 | Twinfix PK FP Suture Anchor | Smith & Nephew, Inc. | 2008 | — |
| 0 (this device) | K093925 | Lifenet System | Physio-Control, Inc. | 2010 | — |
| +1 | K102757 | Lifenet System | Physio-Control, Inc. | 2010 | — |
| +2 | K111296 | Zoll Rescuenetlink | Zoll Medical Corporation, World Wide Headquarters | 2011 | — |
| +3 | K141774 | Zoll X Series | ZOLL Medical Corporation | 2014 | — |
| +4 | K202375 | ZOLL Propaq M | ZOLL Medical Corporation | 2021 | — |
| +3 | K133484 | Zoll X Series | Zoll Medical Corp | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 MSX? 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 MSX device
- #1 K242750 Central Stationscore 21.5 · 31 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 |
|---|---|---|---|
| * | K073509 | Twinfix PK FP Suture AnchorSummary page 2…tal scientific technology, and intended use and is as safe and effective as its currently marketed predicate device, the Smith & Nephew Twinfix PK FP? (K073509). H. Summary Performance Data The performance testing conducted demonstrates that the insertion and fixation p… | 2008 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102757 | Lifenet System | 2010 | 7 |
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 13 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K102757 (Physio-Control, Inc., 2010) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K073509.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, 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 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
The Smith & Nephew FOOTPRINT RCX PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Rotator cuff repair, Bankart repair. Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction. Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot…
Read the full statement (103 words)
The Smith & Nephew FOOTPRINT RCX PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair. Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair. Illiotibial band tenodesis.
Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093925 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093925: Lifenet System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093925
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