510(k) Report

510(k) · Cleared

Cleared

DRG Medium Screw System

K990019510(k) TraditionalCleared Mar 15, 199970-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

Dolphin Medical Technologies, Inc. · HWC Screw, Fixation, Bone

Cleared on Mar 15, 1999 as substantially equivalent to K903810 (Ace Medical Co., 1990) and 6 other predicates after a 70-day review. Its family tree reaches back 1 generation to 1979.

Decided
Mar 15, 1999
Review
70 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
7

Its longest line of descent runs back 1 generation to K792022 (1979). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 2 other ancestors1993: 1 other ancestor1992: 1 other ancestor1990: 1 other ancestor1979: 1 other ancestorK792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalled197519801985199019952000
Other ancestors, by generation 1 generation back: 6 other ancestors K792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalled0
  1. Root · 1 generation backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
  2. This deviceK990019 DRG Medium Screw SystemDolphin Medical Technologies, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K792022Herbert Bone ScrewZimmer, Inc.19796
0 (this device)K990019DRG Medium Screw SystemDolphin Medical Technologies, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
199010
199210
199310
199420
FIG. 1 — Lineage of K990019, 1979–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
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What was it cleared against? (7)

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
*K903810Ace Cannulated Self Tapping Cancellous Bone Screw
Summary page 3
…ces: This product is substantially equivalent in design, composition and function to other orthopedic screws manufactured and approved for market. Ace Medical Company: K903810 Osteomed: K924018 Zimmer: K792022 A.O. Synthes K792291 Aesculap: K940207 Howmedica: K931524 Alphatec Medical: K921622 The DMT DR…
Ace Medical Co.1990—
*K924018M3 Lag Screw Fixation System
Summary page 3
…is substantially equivalent in design, composition and function to other orthopedic screws manufactured and approved for market. Ace Medical Company: K903810 Osteomed: K924018 Zimmer: K792022 A.O. Synthes K792291 Aesculap: K940207 Howmedica: K931524 Alphatec Medical: K921622 The DMT DRG Medium Screw™ Sy…
Osteomed Corp.1993—
*K792022Herbert Bone Screw
Summary page 3
…y equivalent in design, composition and function to other orthopedic screws manufactured and approved for market. Ace Medical Company: K903810 Osteomed: K924018 Zimmer: K792022 A.O. Synthes K792291 Aesculap: K940207 Howmedica: K931524 Alphatec Medical: K921622 The DMT DRG Medium Screw™ System meet the AS…
Zimmer, Inc.19796
*K792291Synthes Reconstructive Plates 'Y' Plates
Summary page 3
…n, composition and function to other orthopedic screws manufactured and approved for market. Ace Medical Company: K903810 Osteomed: K924018 Zimmer: K792022 A.O. Synthes K792291 Aesculap: K940207 Howmedica: K931524 Alphatec Medical: K921622 The DMT DRG Medium Screw™ System meet the ASTM standards (ASTM B3…
Synthes (Usa)1979—
*K940207Titanium Alloy Bone Screws
Summary page 3
…function to other orthopedic screws manufactured and approved for market. Ace Medical Company: K903810 Osteomed: K924018 Zimmer: K792022 A.O. Synthes K792291 Aesculap: K940207 Howmedica: K931524 Alphatec Medical: K921622 The DMT DRG Medium Screw™ System meet the ASTM standards (ASTM B348-83, F136-84, F6…
Aesculap, Inc.1994—
*K931524Fully Threaded Alta Cancellous Bone Screw
Summary page 3
…orthopedic screws manufactured and approved for market. Ace Medical Company: K903810 Osteomed: K924018 Zimmer: K792022 A.O. Synthes K792291 Aesculap: K940207 Howmedica: K931524 Alphatec Medical: K921622 The DMT DRG Medium Screw™ System meet the ASTM standards (ASTM B348-83, F136-84, F67-88) for material…
Howmedica Corp.1994—
*K921622Alphatec Compression Hip Screw System
Summary page 3
…ured and approved for market. Ace Medical Company: K903810 Osteomed: K924018 Zimmer: K792022 A.O. Synthes K792291 Aesculap: K940207 Howmedica: K931524 Alphatec Medical: K921622 The DMT DRG Medium Screw™ System meet the ASTM standards (ASTM B348-83, F136-84, F67-88) for material and design for medical app…
Alphatec Mfg., Inc.1992—

Also cleared against K903810: 11 other devices →

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?

  • 1 of the 7 ancestors has a recall of any class.
  • 11 other devices also cite its predicate K903810.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Dolphin Medical Technologies DRG Medium Screw™ System will be used on indications that are common with presently marketed devices. Specifically, malleolar, radius, ulna, olecranon, displaced fibula and humerus bone fractures. Aditionally, fixation/stabilization of the humeral shaft, distal and proximal humerus, distal and proximal radius and ulna, radial and ulna shaft, distal tibia and ankle, talus-calcaneus-metatarsal, fibular shaft malleolus…

Read the full statement (99 words)

The Dolphin Medical Technologies DRG Medium Screw™ System will be used on indications that are common with presently marketed devices. Specifically, malleolar, radius, ulna, olecranon, displaced fibula and humerus bone fractures. Aditionally, fixation/stabilization of the humeral shaft, distal and proximal humerus, distal and proximal radius and ulna, radial and ulna shaft, distal tibia and ankle, talus-calcaneus-metatarsal, fibular shaft malleolus fractures where indicated; The DRG Medium Screw™ System is indicated for:

Humeral Shaft

Distal and proximal humerus

Distal and proximal radius and ulna

Radial and ulna shaft

Distal tibia and ankle

Talus-calcaneus-matatarsal

Fibular shaft and Malleolus fractures

Intermediate Bone Fractures

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K903810

11 other devices cite the same predicate.

  • K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI…Medos International SARL · 2019
  • K140891Biomet Cannulated Screw SystemBiomet, Inc. · 20145 recalls
  • K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 201217 recalls
  • K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011
  • K060736Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc. · 20061 recall
  • K051296Sijf Cannulated Screw SystemDepuy Spine, Inc. · 2005

More from Dolphin Medical Technologies, Inc.

2 FDA decisions under this applicant name. See the company

  • K973810DRG Large Screw SystemDolphin Medical Technologies, Inc. · 1998

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/K990019 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990019: DRG Medium Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990019

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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