510(k) Report

510(k) · Cleared

Cleared

Universal Compression Fracture Repair System

K081813510(k) TraditionalCleared Mar 12, 2009259-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

U.S. Implant Solutions, LLC · HWC Screw, Fixation, Bone

Cleared on Mar 12, 2009 as substantially equivalent to K954682 (Linvatec Corp., 1996) and 3 other predicates after a 259-day review. Its family tree reaches back 3 generations to 1992. 4 later devices descend from it.

Decided
Mar 12, 2009
Review
259 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K922322 (1992). 9 ancestors in all. 4 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1996: 4 other ancestors1992: 1 other ancestor2021: 2 descendants cleared2024: 1 descendant cleared2023: 1 descendant clearedK922322 · Alphatec 3.5MM Znnulated Cortical Lag Screw · Alphatec Mfg., Inc. · 1992K013534 · Self-Countersinking Bone Screw · Biomet Orthopedics, Inc. · 2001K024086 · Propeller Head Small Cannulated Screw System · Biomet Orthopedics, Inc. · 20031990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors3 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 2 descendants K024086 · Propeller Head Small Cannulated Screw System · Biomet Orthopedics, Inc. · 2003K013534 · Self-Countersinking Bone Screw · Biomet Orthopedics, Inc. · 2001K922322 · Alphatec 3.5MM Znnulated Cortical Lag Screw · Alphatec Mfg., Inc. · 19920
  1. Root · 3 generations backK922322 Alphatec 3.5MM Znnulated Cortical Lag ScrewAlphatec Mfg., Inc. · 1992
  2. 2 generations backK013534 Self-Countersinking Bone ScrewBiomet Orthopedics, Inc. · 2001
  3. 1 generation backK024086 Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc. · 2003
  4. This deviceK081813 Universal Compression Fracture Repair SystemU.S. Implant Solutions, LLC · 2009
  5. Descendant · cites it directly · 3 of its ownK210754 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
  6. Descendant · 2 generations on · 2 of its ownK211290 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
  7. Descendant · 3 generations on · 0 of its ownK242691 OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies · 2024
  8. Descendant · 3 generations on · 0 of its ownK230226 Integrity-SI® Fusion SystemOsteoCentric Technologies · 2023

Most influential descendants

Showing 4 of 4 · See all
  • K210754Cannulated Fasteners and NutsOsteoCentric Technologies · 2021 · cites it directly3descendants
  • K211290Cannulated Fasteners and NutsOsteoCentric Technologies · 2021 · 2 generations on2descendants
  • K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies · 2024 · 3 generations on0descendants
  • K230226Integrity-SI® Fusion SystemOsteoCentric Technologies · 2023 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K922322Alphatec 3.5MM Znnulated Cortical Lag ScrewAlphatec Mfg., Inc.1992—
−2K013534Self-Countersinking Bone ScrewBiomet Orthopedics, Inc.2001—
−1K024086Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc.2003—
0 (this device)K081813Universal Compression Fracture Repair SystemU.S. Implant Solutions, LLC2009—
+1K210754Cannulated Fasteners and NutsOsteoCentric Technologies2021—
+2K211290Cannulated Fasteners and NutsOsteoCentric Technologies2021—
+3K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies2024—
+3K230226Integrity-SI® Fusion SystemOsteoCentric Technologies2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199640
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202120
202310
202410
FIG. 1 — Lineage of K081813, 1992–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K954682Washer, Bolt, Nut, Orthopedic
Summary page 1
…UCT CODE: HTN SUBSTANTIALLY Zimmer 878 Barr Bolt (Pre-amendment) EQUIVALENT DEVICES: Linvatec Corp. Washer, Bolt, Nut, Orthopedic (K954682) Biomet Cannulated Screw System (K024086) Osteonics Osteo 4.0 Cannulated Sc…
Linvatec Corp.1996—
*K024086Propeller Head Small Cannulated Screw System
Summary page 1
…78 Barr Bolt (Pre-amendment) EQUIVALENT DEVICES: Linvatec Corp. Washer, Bolt, Nut, Orthopedic (K954682) Biomet Cannulated Screw System (K024086) Osteonics Osteo 4.0 Cannulated Screw System (K983165) Synthes 4.5mm Cannul…
Biomet Orthopedics, Inc.2003—
*K983165Osteo 4.0MM Cannulated Screw System
Summary page 1
…lt, Nut, Orthopedic (K954682) Biomet Cannulated Screw System (K024086) Osteonics Osteo 4.0 Cannulated Screw System (K983165) Synthes 4.5mm Cannulated Screw (K963172) DEVICE DESCRIPTION: The U.S. Implants CompresSURE Fr…
Osteonics Corp.1998—
*K963172Synthes Sterile 4.5 MM Cannulated Screws
Summary page 1
…ulated Screw System (K024086) Osteonics Osteo 4.0 Cannulated Screw System (K983165) Synthes 4.5mm Cannulated Screw (K963172) DEVICE DESCRIPTION: The U.S. Implants CompresSURE Fracture Repair System is a fracture fixati…
Synthes (Usa)1996—
*—Zimmer 878 Barr Bolt (Pre-amendment)
Named without a submission number
—

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213

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 17 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K210754 (OsteoCentric Technologies, 2021) has gone furthest, with 3 descendants of its own.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The CompresSURE System is indicated for fracture fixation where fracture compression is desired, and where insertion of the nut-and-bolt system does not increase the risk of morbidity due to the need for surgical access to both sides of the compressed area. The device may also be used when compression between separate bones is desired (i.e.- the syndesmosis) as long as there is not increased morbidity associated with the insertion of a nut-and-bolt system, as discussed above.

The system is not intended for spinal use.

Indications for use as stated in the FDA summary.

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K081813 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081813: Universal Compression Fracture Repair System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081813

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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